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The Pharmalot blog reported today that Eli Lilly & Co one of the more progressive big pharma companies to experiment with crowdsourcing and social media to generate new R&D opportunities today announced that it most company employees and executives will not receive base pay increases this year. The company did not announce a freeze in bonuses, however.

In a sign of solidarity with the 99 %, John Lechleiter, PhD Lilly’s outspoken and sometimes controversial CEO, requested that he not receive an increase to his $1.5 million annual salary and incentives. Interesting, as Ed Silverman cogently points out in the Pharmalot post, Lechleiter’s bonus target is 140% of his base salary which put his total compensation for the upcoming year at around $16.4 million!

Last week, the company disclosed that it missed analyst’s stock price estimates and its leading product Zyprexa (antipsychotic) yielded lower than expected sales revenues because of generic competition. Zyprexa sales dropped 44 percent in the fourth-quarter to $749.6 million.

Don’t be surprised if layoffs are next. It may be time for Lilly employees to dust off those CVs and resumes.

Until next time...

 

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Thing have been quiet in the pharma layoff space during 2012. I guess that is not so surprising since we are only one month into 2012. However, there was a post on yesterday’s Pharmalot blog which indicates pharma layoffs may resume in earnest over the next few weeks. 

According to the post, AstraZeneca (AZ) is poised to shed thousands of more jobs after the company announces it earnings later this week. As you may recall, AZ recently announced that it would lay off 400 employees at its US headquarters and eliminate another 1,150 jobs from its US sales force. Like other pharmaceutical companies, things have been tough for AZ as three of its blockbuster products Crestor (cholesterol lowering), Nexium (acid reflux) and Seroquel (antipsychotic) lose patent protection and face stiff generic competition.

The Pharmalot post also reported that:

“Between 2007 and 2009, AstraZeneca eliminated 12,600 positions, a move that saved $1.6 billion annually, although that figure rose to $2.4 billion by 2010. The cuts announced that year were designed to save $1.9 billion annually by 2014 It is not clear how much the drug maker hopes to save with still more cuts, but some $3 billion may be spent on a stock buyback to bolster shareholder confidence.”

It is important to note that the massive downsizing that has taken place in the pharma industry over the past decade has little to do with the recession and everything to do with the loss of blockbuster revenues due to generic encroachment. Put simply, most pharma companies grew too large too quickly and subsequently realized that could not sustain their vast infrastructures if the loss of blockbuster sales revenues could not be replaced by new products. To wit, if you look at the P&L statements of many pharmaceutical companies, most have $5 billon to $30 billion of readily-available cash reserves on hand to “play” with. Sadly, the downsizing that has taken place had little to do with the present and everything to do about the future profitability of big pharma companies.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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Let’s start with the good news first. A report issued by the National Capital Association and PricewaterhouseCoopers found that venture capital investment in biotechnology grew 22 percent in 2011. And, now the bad news; initial funding for biotechnology startups seeking investment hit a 16 year low last year. The consensus among financial analysts is that life science investors are increasingly focusing on later stage companies because they carry less clinical and regulatory risks as compared with early stage ones. Put simply, VCs, like everyone else, have become much more risk adverse and do not want to invest in companies that don’t have a minimum history of success.

According to the report, venture firms spent $4.73 billion on 446 biotechnology companies in 2011, the highest dollar amount since 2007. Approximately, 153 biotechnology and medical devices companies received their first round of funding last year.

Finally, the US Food and Drug Administration approved 30 drugs in 2011; 13 of which were developed in part by venture funding.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!

 

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The past several years I have been touting healthcare informatics technology (HIT) as an alternate career option for life scientists. For those of you who may not know, healthcare informatics is a field tasked with organizing, mining and distributing electronic health records (EHRs) to physicians and other healthcare providers. Persons with a background in medicine/biology and familiarity with computer software and managing and manipulating large digital data sites are ideal candidates for HIT jobs

The US federal government is mainly responsible for the growth of the US HIT field because it is offering financial incentives (mandated in the 2009 federal stimulus package) to healthcare providers who switch from paper to EHRs. The government began to disburse the money last May to those institutions and providers who applied for the funds. To date, hospitals and healthcare providers have received $2.5 billion of a potential $27 billion in stimulus funds.

At present, nearly 40 percent of American primary care physicians and approximately 25 percent of hospitals use EHRs. Thousands more are likely to adopt EHRs this year to qualify for federal stimulus monies. 

So, which major companies are hiring health informatics employees? They include:

1. Epic Systems
2. Allscripts
3. Meditech
4. Cerner
5. IBM
6. McKesson
7. Siemens
8. GE Healthcare

Of course, there are smaller companies and start-ups that are also looking for health informatics employees. To that end, persons with a strong background in biology who are comfortable writing code or working with software packages that handle large datasets ought to consider careers in HIT.

Until next time...

Good Luck and Good Job Hunting (check out Epic in Madison, WI)

 

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Despite the fact the US unemployment rate has hovered around 9.0 percent for the past several years and over 200,000 pharmaceutical employees have lost their jobs since 2001, many life sciences executives contend that they cannot find qualified employees to fill job openings at their companies. Most executives blame the US education system for not providing prospective employees with necessary training and immigration laws that prevent companies from hiring highly-skilled foreign workers. According to a recent survey conducted by the staffing company ManpowerGroup, over 52% of US employers that they have difficulty filling open positions because of talent shortages.  Some other revealing statistics about employer’s attitudes include:

• 47% of employers blame job candidates’ lack of hard job or technical skills for their inability to hire
• 35% of companies cite job candidates’ lack of experience as a reason not to hire
• 25% blame lack of business knowledge or formal educational qualification as a deterrent to hiring

While a majority of US corporate executives may believe this, the reality is that employers simply cannot find employees to accept jobs at the wages that they are willing to offer! In other words, there is a plethora of skilled American workers out there; but many US employers are willing to outsource or hire skilled foreign nationals who frequently work for lower wages than most Americans. Further, American employers are unwilling to spend money to train college graduates or re-train existing employees who may be able to step into these so-called difficult-to-fill positions. This may help to explain why an increasing number of students are willing to accept unpaid internships or, in some cases pay to work at companies for free to garner valuable industrial experience which may ultimately lead to a job.

In a recent article in the Wall Street Journal, Peter Cappelli, the George W. Taylor Professor of Management at the University of Pennsylvania’s Wharton School, offered three possible solutions to the current American unemployment conundrum

Work with education providers

If job candidates lack the skills or qualifications to do certain jobs, companies ought to make them go to school to acquire them. To that end, a growing number of community colleges in North Carolina and New Jersey have partnered with prospective employers to develop courses or degree programs tailored to meet their employment needs. For example, about 10 years ago my local community college (Mercer County College) developed a program (in a partnership with the clinical research company Covance) to train students interested in becoming clinical research assistants and managers. Not surprisingly, many of the students enrolled in the program ultimately where hired by Covance. 

In another variation of this model, extant employees, who may be interested in advancing their cares, would be able take classes at local community colleges (in off hours) and have their tuition subsidized via company tuition reimbursement programs. This would help to obviate the high costs and inordinate amount of time typically required to hire external candidates for newly created positions.

Reintroduce on-the-job training programs

Back in the day, companies tended to hire persons who were the brightest, most talented and most likely to benefit an organization.  New hires were required to participate in internal training programs so that they would better understand their positions and allow management to best evaluate new talent. Generally speaking, this allowed most companies to operate more efficiently; mainly because this allowed managers to determine the best fit of new hires into the existing corporate structure. Sadly this is no longer the case at most companies. These days, companies tend to hire worker who possess the technical skills and qualifications to do a certain job and are expected to “hit the ground running” Put simply, short term needs are placed before the long term needs and future success of an organization.

Promote from within

According to data from the talent management company Taleo Corp., in recent years a surprising two-thirds of job vacancies, even in larger companies, have been filled by outside hires. While it may be cheaper to hiring from the outside, the loss of experienced workers and historical corporate knowledge may affect a company’s performance and ultimately its bottom line.

While the US economy is beginning to show signs that it is beginning to recover, I believe that surest way to prosperity is to put Americans back to work. Although this may require a substantial financial investment by US corporations, we simply can no longer rely on outsourcing or a cheaper immigrant workforce to allow American to continue to compete on the world stage.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Fierce Biotech conducted its annual survey to identify top female executives in the biotechnology industry. After receiving 130 nominations, they compiled a Top 10 List for 2011.  While some notable women executives may not have made it onto the 2011list, there is always next year.

Their list is as follows:

1. Katrine Bosley—CEO, Avila Therapeutics
2. Susan Desmond-Hellman, MD—Chancellor of USCF (formerly @ Genentech)
3. Deborah Dunsire,MD—President and CEO, Millennium, the Takeda Oncology Company
4. Carol Gallagher—CEO, Calistoga Pharmaceuticals
5. Melinda Gates—Co-Founder and Co-Chair, Bill and Melinda Gates Foundation
6. Maxine Gowen, PhD, MBA—President and CEO, Trevna
7. Rachel King—CEO, GlycoMimetics
8. Tina Nova, PhD—CEO Genoptix Medical Laboratory
9. Gail Schulze—CEO& Executive Chair of the Board, Zosano
10. Daphne Zohar—Pure Tech Ventures

If you think that someone who is not on the list deserves to be there, add a comment to this post.

Congrats to the women who made the list!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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About two years, I posted an opinion piece on BioJobBlog which argued that pharma’s reluctance to engage in social media because of fears of being swamped with adverse events (AEs) reports was little more than a red herring.

In that piece I opined “what is really at stake, is the systemic changes that would be required to transform a historically, opaque and unresponsive industry into a transparent, accountable and responsive one that would be required if it embraces social media as an integral part of its business model.” Nevertheless, two years later, there is still no FDA guidance on the use of social media in the pharmaceutical industry and while some companies have warmed up to the concept, it has not been wholly embraced by most companies.

However, there is new data that may put the “fear of being swamped by AEs reporting” argument to rest. The Pharmalot Blog reported today that a new study conducted by Visible Technologies, a social media monitoring and software firm, showed that only 0.3 percent of more than 257,000 posts about 224 different products —33 antacid over-the-counter meds, 38 over-the-counter decongestants, 10 prescription statins and 143 prescription drugs used to treat high blood pressure—mentioned an AE. For a more detailed analysis of the study please click here.

According to the Pharmalot post the study was conducted over a recent 30-day period and posts were collected from millions of social media sources including “blogs; forums; message boards; message groups; social networks, notably Facebook and LinkedIn; Twitter; regular news sites; specialized health sites, such a WebMD; and video and photo sites, such as YouTube and Flickr.” The study’s focus on statins, blood pressure medications, over-the-counter decongestants and antacids was intentional because tens of millions of persons use these products and therefore, would be more likely to comment on them at social media sites. The bottom line: the use of social media by pharma companies will not overwhelm their existing AE reporting networks nor will it require that more persons be hired. In fact, as I argued in my previous post, using social media for AE report may actually help companies better managed approved and marketed drugs as part of their FDA-required post marketing drug surveillance programs. 

At this point, I am at a loss as to why pharma has not yet embraced social media and leveraged it to their advantage like other industries. I suspect that most companies will not act until FDA issues the social media guidance it has been promising for the past two years. Sadly, it is anyone’s guess when the agency will finally issue the guidance—it has already been delayed several times over the past two years!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Last week, the US Food and Drug Administration issued a press release lauding its approval of 35 new prescription medications in FY2001. According to the release 2011 was a banner year for drug approvals; being only surpassed in FY2009 when 37 new medicines garnered regulatory approval.

FDA detailed its accomplishments in a report entitled “FY2011, Innovative Drug Approvals” which touted faster approval times in the United States as compared with the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines. 

Among this year’s highlights:

1. Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
2. Seven of the new medicines provide major advances in cancer treatment;
3. Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
4. Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
5. Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
6. Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
7. Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program
8. Thirty-four of 35 were approved on or before the review time targets agreed to with industry under The Prescription Drug User Fee Act  (PDUFA), including three cancer drugs that FDA approved in less than six months.

PDUFA was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012. 

Maybe the agency can keep its streak alive before  PDUFA expires next year!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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Blogs first began appearing on the web about 10 years ago and most experts agree that they ignited the social media revolution. While blogs are the oldest form of social media, many pharma companies are reluctant to contribute to the content of the blogosphere. This is mainly because of perceived regulatory and legal issue and consequences. Nevertheless, a few intrepid big pharma companies have taken the social media plunge and currently maintain blogs with various formats and content.

From time to time, Mark Senak, author of the outstanding EyeonFDA blog, likes to check up on pharma to see how their social media experiments are going. In a post today, entitled “A Profile on Blogging By Pharma and FDA” he provides an update on pharma bloggers who he thinks are making a contribution to the life sciences community. The following is Mark’s assessment:

Johnson & Johnson–With JNJBTW, J&J has been blogging longer than any other pharma company with an archive going back to June 2007.  JNJBTW provides works to forge relationships with a broad spectrum of healthcare consumers by providing insights and resources for a variety of treatment related issues and profiles of company activities.  The blog haws multiple authors and accepts comments, though reviews them before posting according to the comments policy.  The blog has its own domain.

GSK–The More Than Medicine blog goes back to January 2009 and uses multiple authors to cover a wide span of subject matter that includes corporate social responsibility topics, chronic diseases, and current events. According to its comments policy, the blog allows for moderated comments. Entries can vary in terms of timing; with all three entries for October appearing on the same day.

AstraZeneca–Like JNJBTW and More Than Medicine, the AZHealthConnections blog takes a generalist approach by providing information on a broad spectrum of subject matter – some disease or condition specific in the areas of cancer and diabetes – but also including a public policy and general healthcare information. Residing in its own domain, the earliest archive is in October 2009 and the blog permits moderated comments according to its comments policy.

Lilly–The blog LillyPad is a more recent entry to the blogosphere begin in third quarter 2010, though no archive link is available on the landing page. LillyPad was started with a twitter handle as well of the same name, and more recently joined by a LillyPad YouTube channel called the Lilly Health Channel. The posting on the blog have frequent postings related to public policy and advocacy issues, though there is sometimes a posting on social responsibility or what it is like to work at the company. However, the focus on advocacy and policy issues (supporting innovation) seems to drive this effort in a very specific direction – being less generalist than other approaches. The comments policy is at the end of a post and states that comments are filtered – or moderated – by the company before posting.

Sanofi US–Here a company has taken a much more specific approach with a blog called Discuss Diabetes. The archive goes back to January 2011 and is therefore the newest entry and has the distinction on being the only disease/condition-specific target audience.  The blog, with its own domain, accepts and moderates comments. The focus is to provide information and resources regarding diabetes and resources for those who have it or are care partners, including such assets as its own mobile app for diabetics – Go Meals.

Pfizer–The Think Science Now blog on the Pfizer site has multiple authors who write to translate the science of medical research, though it lacks some of the traditional characteristics of a blog, such as an archive or commentary policy that was readily apparent. However, it is exemplary of the effort to aim at a specific audience of people rather than go broadly to the consuming public.

FDA–The FDA Transparency Blog first posted in November 2008 and was originally set to run for six months.  The purpose is to provide insight into how and why the agency comes to some of its decisions.  It does not have its own domain but is contained in the labyrinth of the FDA’s website.  The blog allows for moderated comments according to its comments policy, though I have not found that to necessarily be the case.

As you can see, there are not many pharma companies that maintain corporate blogs. Perhaps this may change after FDA releases it guidance on the use of social media in the life sciences industry. That said, it is anybody’s guess as to when that guidance will be issued; it already has been two years and there is no guidance yet!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

 

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Despite the initial pushback against social media by many pharma and biotech companies it appears that Twitter is emerging as the medium of choice for the life sciences industry. The main reasons for this trend are the 140 character world limit and the real time nature of Twitter. Unlike Facebook pages and blogs, where visitor’s comments (of any length) remain for indefinite periods of time, the information contained in tweets is minimal and their exposure time is second or minutes rather than days or months. These features allow pharma and biotech companies to more easily manage information flow and quickly implement damage control when necessary. 

Because of the growing importance of Twitter in life sciences circles, Mark Senak, the intrepid author of the EyeonFDA blog and a self-proclaimed social media enthusiast, compiled a list of well, useful pharmaceutical Twitter lists. Twitter users can subscribe to lists which are a compilation of tweets from persons who belong to the lists. For those of you who use LinkedIn, Twitter Lists are analogous to LinkedIn Groups.

Mark recommends the following lists to those who want to follow the pharmaceutical/healthcare industry

Healthcare Reporters 

Pharmaceutical Manufacturers 

Device  Manufacturers

Medical Journals

FDA Twitter Feeds.

Government Healthcare

Pharmaceutical and Biotech Jobs

To view these lists you must be a Twitter member!

Hat tip to Mark and to John Mack at the Pharma Marketing Blog for the Twitter image!

Until next time...

Good Luck and Good Tweeting!!!!!!!

 

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About a year ago, I suggested that real time social media platforms like Twitter could be invaluable tools for adverse event (AE) reporting and related pharmacovigilance activities. However the mere mentioned of the dreaded AE causes many marketing, legal and regulatory affairs professionals at major pharmaceutical companies to break out into a cold sweat. 

As Mark Senak aptly pointed out in a recent post on his blog EyeonFDA,

“...the reporting of adverse events using social media has long been the bogeyman feared by the legal and regulatory departments of drug manufacturers in the US.”

Further, Mark rightly asserts:

“....the adverse event issue may have proven a red herring.  That is perhaps evidenced by the now large number of Twitter feeds that are active representing pharmaceutical manufacturing companies and even their products; the growing, though not as quickly and not with as much success, presence of YouTube channels; the large number of Facebook pages and even an uptick in the number of corporate sponsored blogs – now at five by my count.  If the adverse event reporting issue really were an issue, this presence would be shrinking, not growing.”

So, what is the “real reason” why drug manufacturers refuse to embrace social media like almost every other industry that I can think of? True, FDA has not yet issued its long awaited guidance on the use of social and digital media in the life science industry. But, the lack of guidance has not prevented pharma and biotech companies from innovating in the past. I suspect that one of the reasons why many companies refuse to adopt social media is the requisite transparency and interactivity that are typically associated with its use. And, perhaps more importantly is the perceived loss of control over product messaging that companies with approved drugs on the market have enjoyed for the past 50 years or more.

Whatever the reasons are, I still contend that social media platforms are ideal tools for AE reporting and pharmacovigilance activities. Hopefully, drug makers will come to realize this with or without FDA guidance on the topic.

Until next time...

Good Luck and Good Tweeting!

 

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A report in Bloomberg News today suggested that Eli Lilly & Co. Chief Executive Officer John Lechleiter, PhD told a technology conference today that unfavorable US permanent resident (green card) laws are to blame for declining US innovation in the life sciences. With this in mind, Lechleiter plans on calling for US immigration officials to issue more green cards and adopt a shorter and simpler process for highly skilled foreign nationals to gain permanent residence in the US. According to Dr. Lechleiter, one of only a handful of big pharma CEO who is also a PhD-trained scientist, current green card regulations are so-called job killers and force many talented foreign nationals to return to their native countries to work with firms that directly compete with American life sciences companies. Unlike most of his peers, Lechleiter has been very outspoken about the lack of US life sciences innovation.

While Lechleiter comments may have been appropriate five or more years ago, they are no longer germane to America’s waning innovation in the life sciences. There is little doubt that many bright and talented foreign nationals were denied permanent residency during the Bush era (2000 to 2008) because of stringent immigration policies and limits on the numbers of green cards allotted for persons from certain parts of the world; mainly China, India and the Middle East. This, in turn, forced many life scientists—many of whom desperately wanted permanent residency in the US—to return to their home countries to look for work and gainful employment.

As Lechleiter rightly asserts, these scientists found work with companies that began to directly compete with US life sciences. This phenomenon, coupled with the rapid assent of the middle class in many of these nations, made it possible to begin to conduct Western style research at a much lower costs in these countries. To that end, by 2007, most big pharma companies—many of whom had dwindling pipelines and monstrous overhead costs—realized that it would be more cost effective to outsource or move R&D to countries with emerging pharmaceutical and biotechnology markets and a well trained R&D workforce. And, for the past four years downsizing and outsourcing of R&D are exactly what have been taking place at many American big pharma and biotechnology companies.

In my opinion, the larger question that must be addressed, as far as US innovation in the life sciences is concerned is: why are so few Americans willing to pursue scientific careers? To wit, the main reason why so many foreign life scientists were educated and trained in the US over the past 20 years was because there weren’t enough American students to fill the incoming roster at most American graduate training programs. Put simply, America’s growing lack of innovation in the life sciences over the past decade can be directly attributed to far fewer Americans pursuing scientific careers and an increased reliance on foreign nationals—who were unable to stay in the US—to innovate! While changing US immigration laws may allow some foreign nationals to more easily remain in the US, there simply aren’t enough life sciences jobs left in the US to make it worth their while! In fact, the likelihood of them finding life sciences jobs in their home countries is now greater than it is in the US. In my opinion, the only way to restore American innovation in the life sciences is to convince American students that pursuing scientific careers is worthwhile and that the requisite training for industry jobs is available to them.

Interestingly, after leading with changes to US immigration laws, Lechleiter also suggested that America’s innovation problem could be solved by lowering US corporate tax rates and American companies should not be forced to pay taxes on oversea earnings. Also, he asserted that the US Food and Drug Administration (FDA) should stop putting off decisions or erring on the side of avoiding risk when considering new drug applications. 

This begs the questions, how do lower taxes, no overseas taxes and expedited drug approvals help to spur American innovation when most life sciences R&D is conducted outside of the US?

Until next time...

Good Luck and Good Innovating!!!!!!!!

 

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The tough job market and economy have caused lots of folks to consider changing careers to find gainful employment. While sometimes a career change is warranted, it may not be as easy as you think. With this in mind, there was a great article entitled "The Big Switch, One Step at a Time" by Phyllis Korkki that provides some tips and insights to think about before taking the big plunge.

Of course, not all career changes are created equal and there are a variety of things to consider depending upon whether you are starting out or a midcareer person. I think that the best bit of advice that was offered for all persons considering a career change was a recommendation to read industry trades and follow industry blogs; mainly because they are not translated for the general public. That said, if you find yourself reading these publications and you don’t know what certain acronyms mean or you are having difficulty understanding the points that the authors are trying to make, it is a good indication that transitioning into that career may take a little more training and understanding than you think!

Until next time...

Good Luck and Good Career Hunting!!!!!!!

 

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One of the new “hot career” opportunities in the life science industry is something called a medical science liaison or MSL. Increasingly, graduate students and postdocs are beginning to mention MSL as a possible career option. Of course, the first thing that I ask these persons is “Do you know what an MSL is or does on a daily basis?” In most cases, most of these would-be MSLs sheepishly admit that they don’t!

With this in mind, I invited Dr. Samuel Dyer an experienced MSL and CEO and Founder of the Medical Science Liaison Corporation and MSL WORLD to better inform those who may be interested in pursuing a career as an MSL.

What is a Medical Science Liaison?

By Samuel Dyer

The MSL is a therapeutic specialist (e.g. Oncology, Cardiology, Infectious Diseases, Central Nervous System) within pharmaceutical, biotechnology, medical devices, and clinical research organizations (CRO) who has advanced scientific training and generally a "terminal D" degrees in the life sciences (PhD, PharmD, MD).  It's important to note that MSL's are not sales reps and their function is very different.  The primary purpose of the MSL role is to be scientific or disease state experts for internal colleagues (sales and marketing), but more importantly for doctors in the Therapeutic Area of the Medical community in which they work (i.e. Oncology, Cardiology, CNS etc.).  The focus of the role has changed over the years, but the primary responsibility of the MSL role remains to establish and maintain peer-peer relationships with leading doctors, referred to as Key Opinion Leaders (KOL's).

Medical Science Liaison’s (MSLs) were first established by Upjohn pharmaceuticals in 1967 as a response to the need for professionally-trained field staff that would be able to build rapport with Key Opinion Leaders (KOLs) in various therapeutic areas of research. Although originally called Medical Science Liaisons by Upjohn, over the years and today, pharmaceutical companies have used various names for the role including: Medical Liaisons, Medical Managers, Regional Scientific Mangers, Clinical Liaisons, and Scientific Affairs Managers among others.  

Originally, the first MSLs were selected from experienced sales representatives that had strong scientific backgrounds to bring a higher degree of clinical and educational expertise to the medical professionals they were working with to influence sales. Over the years, MSL teams have been made up of individuals with various scientific backgrounds including: “super” sales reps, those with nursing backgrounds, those with various doctoral level degrees or other clinical backgrounds.  However, the required educational and scientific background and purpose of MSL’s has progressively changed over the years since they were first established.  In the late 1980’s, a number of companies began to require those applying to MSL roles to hold a terminal “D” degree such as an MD, PharmD, or PhD degrees.  

Although, historically, the educational standard in the industry did not require MSL’s to have a terminal “D” degree, however, today the terminal “D” degree has become standard in the industry.  Today according to one benchmark study more than 90% of current MSLs hold terminal “D” degrees.  

While the MSL role has received some attention, including a CNN Money article entitled "#1 Job in Pharmaceuticals-10 Jobs for Big Demand-Good Pay”, it remains one of the best kept secrets and one of the most difficult roles to break into.  Few people know about it, and little is written about the role.  In fact, the MSL community is quite small when compared to other professions in the pharmaceutical industry however there has been an explosion in the growth of the position. According to a recent benchmark study, there has been an average growth of 76% of the MSL role since 2005 across the industry in the U.S.

To learn more about the MSL role and find free resources go to www.mslworld.com

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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There is no longer any doubt that big pharma companies are beginning to reduce their emphasis on internal R&D activities. Instead the companies will increasingly rely on outsourcing, partnerships, closer collaborations with academia, public private partnerships and M&A to keep their drug development pipelines full

Therefore it was not surprising when Merck’s new CEO, Kenneth Frazier recently mentioned in a conference call to financial analysts and investors that its multi-billion spending on new drug R & D will likely decline as a percentage of overall sales in the coming years. Merck is one of the largest pharmaceutical companies in the world

According to an article on Nasdaq.com, in 2010, Merck spent $11 billion on R&D, or 24% of total sales. Adjusted to exclude certain acquisition-related and other costs, R&D spending was $8.1 billion. Merck has predicted 2011 adjusted R&D spending would be $8.1 billion to $8.5 billion for 2011.

Frazier, the first African American CEO of a major pharmaceutical company, came under pressure earlier this year after he decided to not substantially cut R&D as many of Merck’s rivals, most notably Pfizer, did. He noted that cuts in R&D spending would have jeopardized Merck’s long term product development pipeline.

While rumors persist that Merck may be seeking to jettison its non-pharmaceutical consumer health and animal health businesses, Frazier insisted that the two units are complementary to its core pharmaceutical and vaccine focus and are not for sale. That said, if I was a Merck employee in either of those divisions, I would be updating my resume just about now.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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A graduate student friend of mine suggested that his research project was very similar to a video entitled "The Bad Project Video (Lady Gaga Parody)."  The video based on the Lady Gaga hit song "Bad Romance" was produced by members of the Zheng Lab who study Alzheimer's disease at Baylor College of Medicine. The lab unveiled its video at their annual 2011 Molecular and Human Genetics Retreat. 

To date, the video that was posted on YouTube has already amassed over 2.7 million hits an almost unprecedented number of hits for a science video! Members of the lab posted this introduction at their YouTube site:

"Thanks everyone for your comments and words of encouragement! We had no idea this would spread like it has, but I guess some of these feelings are universal (and international!). This was all in good fun and took us only a few days to do the filming and editing. If you are caught in a bad project, best of luck and hope you can turn it around soon!"

Unfortunately, the video accurately depicts the daily lives of  many graduate students and postdoctoral scientists struggling to jump start careers in the life sciences.  In any event, it is a well produced and hilarious attempt to show graduate students and postdocs that they are not alone and that there may be light at the end of the tunnel. 

Until next time..

Good Luck and Hang In There!!!!!!!!

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The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business. 

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

 

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After a long drought, venture capital and private equity investments into private life sciences companies are beginning to flow again. VCs and fund managers have monies that must be invested into promising new ventures. The best way to find the right investors is to present at life sciences investment fairs like LifeScienceFest Americas. This year BioJobBlog and BioCrowd are cosponsoring the event.  

If you are interested in presenting your company to qualified investors, please read the information presented below and take advantage of discounted rates.

APPLY NOW TO PRESENT AT LIFESCIENCEFEST AMERICAS - JUNE 17, 2011
Investorfest Media is proud to announce call for nominations from promising startups for
LifeScienceFest Americas conference on June 17th.  At the 3rd annual venture conference, we will showcase up to 16 promising innovators seeking funding to active life science angels and investors.

APPLICATION DEADLINE : MAY 14, 2011
If you are a startup (seed, Series-A,B,C or restart) from the medical device, diagnostic or
healthcare technology space and you are seeking new investment to start or grow to the
next level, this is THE conference for you. You must be seeking funding from $250K to
under $20M. Learn more on the application process, segments of interest and deadlines.

CONNECT WITH LEADING INVESTORS AT LIFESCIENCEFEST
General Partners & angels from 20+ leading firms including Sand Hill Angels, Band of Angels, Keiretsu Forum, Claremont Creek Ventures, Bay City Capital,Physic Ventures, Psilos Ventures, Sofinnova Ventures,  Lumira Capital and many others will be at the event. Learn more..

WHO SHOULD ATTEND

Investors from Founders of promising innovative companies seeking capital to industry executives, investors and M&A professionals will be in attendance at this exclusive, limited seating event. Non-presenting entrepreneurs can also attend, and must register early to reserve their spot. Register Now to reserve your spot

BIOJOBBLOG BIOCROWD MEMBER DISCOUNT
A limited number of discounted tickets are available for Biocrowd members who will receive $50 off early bird registration and pay just $299. Apply code BIOCR50. Discounts are offered to qualified non-service provider professionals from the life science and med device industry and on a first-come, first-serve basis. Register Now at the discounted rate.

ABOUT INVESTORFEST MEDIA
Investorfest Media is the leading VC funding accelerator working in the life science and medical device space. Through our highly focused training and hands on support, qualified companies are put in front of specially chosen investors our annual LifeScienceFest conference. To date over 75% of presenting companies have gone on to receive funding, with over $280 million being raised since 2006. Learn more at investorfest.com

Until next time

Good Luck and Good VC Hunting!!!!!!

 

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The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Ross Perlin has written a book entitled “Intern Nation How to Earn Nothing and Learn Little in the Brave New Economy” that takes a critical look at the role of internships in today’s job market. Perlin, a former unpaid intern himself, contends that American companies are taking advantage of college students who believe that internships, paid or otherwise, are the only way to land a job in today’s economy. He estimates that each year 1 to 2 million persons take “resume burnishing” internships to increase the likelihood of downstream employment.

Recent estimates made by the College Employment Research Institutes suggest that as many as three quarters of approximately 10 million American students at four year colleges and universities will complete at least one internship before they graduate. Internships can be found almost everywhere a college student looks for them including; Fortune 500 companies to Disneyworld to Capital Hill to Silicon Valley to Main Street Experiences can range from fetching coffee to cleaning toilets to more substantive activities but almost always at little or no pay. Perlin noted that the number of internships that are “school-like, full-time dedicated training programs is vanishingly few.” Further, he astutely observes that the internship craze has taken on a life of its own and is supported by on-campus career centers, online middlemen and many employers looking for free entry-level workers.

While Perlin sees the value of structured and paid internships he rightfully excoriates academic career centers for offering unpaid internship opportunities to their students. To wit, he wrote: “An overwhelming majority of colleges and universities, as well as some high schools, endorse and promote unpaid internships without a second thought, provide lucrative academic credits that employers wishfully hope will indemnify their firms, and justify it all with high minded rhetoric about situated learning and experiential education” he wrote. Further, he is incredulous that some employers “require not only that their charges work for free, but that they also obtain academic credit, which usually means paying (tuition and fees) to work for free.”

There is no question that college internships once gave students who took advantage of them a “leg up” on the competition. However, the sheer number of available internships has relegated them to little more than a box to check on a job application. In other words, internships are quickly becoming a requirement rather than an option. Moreover, according to Perlin, prospective employers are becoming increasingly aware that “these experiences (internships) can mean just about anything: your parents are well connected, your school required it, your barely showed up at the office. ”That, if you were counting on your experience as an intern to make a difference between gainful employment or not, it may be time to rethink your strategy.”

Because the life sciences companies are almost always behind their non-scientific counterparts, most internships offered by pharmaceutical and biotechnology companies continue to be paid, structured and training-minded. With this in mind, many of my former students (primarily those who were motivated and good at networking) were able to transform internship experiences into full-time employment. However, internships have unfortunately replaced many industrial postdoctoral training programs: which may be good for graduate students but not so good for PhDs looking for industrial postdocs to transition from academia to the private sector.

Despite the growing criticism and problems with internships, I still think they are a viable approach for students and postdocs to acquire the “prior industrial experience” that is now necessary for academic scientists seeking job opportunities in the life sciences industry. Needless to say, once the life sciences industry “catches on” to the ways that internships can be manipulated and leveraged to their advantage, they will no longer be the “tickets to employment” at pharmaceutical and biotechnology companies that they once were.

Until next time....

Good Luck and Keep the Faith!!!!!!!!!

 

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Mathew Herper, who writes at the Forbes Blog, reported today that according to a report compiled by the outplacement firm Challenger, Gray and Christmas, since 2000 the pharmaceutical industry cut 297,650 jobs. According to Herper “that is about as many people as currently work at the three largest drug makers — Pfizer, Merck, and GlaxoSmithKline — combined.” As he aptly points out “Many of those who were laid off were probably hired back by other drug makers. Some folks have probably been laid off more than once. It’s also worth noting that big mergers are one reason for the cuts.”

Nevertheless, the number of lost jobs is staggering. Interestingly, while almost 300,000 jobs have been lost in the last decade, a majority of the cuts (234,814) have taken place over the past six years (see below).   It is not clear from the report whether or not these numbers include the numbers of jobs lost by the aggregate life sciences industry (including biotech and specialty pharma) or only by the pharmaceutical sector.    

Year	No. Jobs Lost
2000	2,453
2001	4,736
2002	11,488
2003	28,519
2004	15,640
2005*	26,300
2006*	15,638
2007*	31,732
2008*	43,014
2009*	61,109
2010*	53,636
2011 (to date)	3,387
TOTAL	297,650

   Source: Challenger, Gray & Christmas, Inc. © (via the Forbes Blog)

With mergers on the way and more jobs being outsourced to Asia and elsewhere, don’t be surprised if the total number of layoffs continues to grow.

Until next time

Good Luck and Good Job Hunting!!!!!!!!!!

 

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By now, most BioJobBlog readers are aware that internships (paid or otherwise) have become a prerequisite at many companies to secure a full time employment. While I think internships are a great idea to jumpstart a career, not all internships are created equal or worth it. Put simply, it is up to the prospective intern to determine whether or not the advantages outweigh the disadvantages. Nevertheless, according to a report by the College Employment Research Institute three-quarters of the 10 million American students enrolled at four year colleges and universities will work as an intern before graduating. 

The increasing popularity of internships has been mainly promulgated by American colleges and universities who—according to Ross Perlin the author of “Unpaid Interns, Complicit Colleges”—have become “cheerleaders and enablers of the unpaid internship boom failing to inform young people of their rights or protect them from the miserly calculus of employers.” While Mr. Perlin’s comment may sound a little critical—especially to those who have either worked as unpaid interns or are slated to work as one this summer—he has a point both legally and morally. To wit, the United States Department of Labor says that an intern for a for-profit company may work without pay only when the program: 1) is similar to one offered in a vocational school; 2) benefits the student; 3) does not displace a regular employee and 4) does not entitle the student to a job. Further, the employer must derive “no immediate advantage” from the student’s work and both sides must agree that the student is not entitled to wages.

Interestingly, in an attempt get around the regulations, many fortune 500 firms and other companies have cut deals with some colleges and universities to offer its students equivalent college credit for the internship experience.  “Not so fast” says the Labor Department; “academic credit alone does not guarantee that the employer is in compliance.” To overcome this objection, some colleges have actually asked interns to pay for the credits, thereby justifying an unpaid internship experience. While this may legitimate in some cases, Mr. Perlin laments:

“Charging tuition for students to work in unpaid positions might be justifiable in some cases—if the college plays a central role in securing the internship and making it a substantive academic experience. But more often, internships are a cheap way for universities to provide credit—cheaper than paying for faculty members, classrooms and equipment.”

In support of this, a recent survey of more than 700 colleges and universities found that 95 percent allowed the posting of unpaid internships in campus career centers and on college websites! And, only 30 percent required their students obtain credit for the unpaid internship experience. The remainder, according to Mr. Perlin: “evidently, were willing to overlook potential violations of US labor laws.”

An easy fix for the unpaid internship crisis would be for colleges not to publicize (or post) unpaid for-profit company internships. Further, many colleges and universities should eliminate the internship requirement for graduation. Finally, colleges and universities should stop charging students to work without pay—that is simply un-American!

Coincidentally, the unpaid internship trend coincides with other disturbing economic and labor trends like the growing numbers of adjunct professors, contract and temporary workers and freelancers who live paycheck to paycheck. Moreover, the growing push for unpaid internships eerily coincides with recent attempts by state governments to eliminate collective bargaining rights for public employee unions. Both are attempts to weaken organized labor and labor laws in this country. For those of you who may not know, it was the labor movement that abolished child labor, established a 40 hour work week, guaranteed overtime pay and provided workers with two weeks vacation each year. 

Finally, colleges and universities and for-profit US companies that exploit college students as unpaid interns ought to be morally ashamed of themselves. College tuition is already expensive enough and most companies have the financial resources to pay their interns minimum wage. If a company can’t afford an intern’s nominal salary maybe that company shouldn’t be in business.  To that I say, whatever happened to the quintessentially American ideal—“fair wages for honest work?”

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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I first heard about informational interviews two years ago at the Annual Biomedical Research for Minority Students (ABRCMS) at which I was reviewing resumes and offering career advice. I asked the student who mentioned the interviews exactly what they are. And, much to my surprise, I learned that the process involved approaching a “professional” to set up a meeting to discuss possible career paths at a company that a jobseeker was interested in. 

At first blush, it sounded like a terrific idea to me. Unfortunately, the concept presupposes that jobseekers have done their homework and identified prospective companies that seem “like a fit” for them.

Second, it also presupposes that job candidates have a clear understanding of the duties and responsibilities of career options available at prospective companies. For example, several years ago many scientists who wanted to get out of the laboratory frequently mentioned business development as a possible alternate career options. In response to the question, I always ask “Do you know what business development professionals do on a daily basis and what skill sets are required to be successful at that job? Not surprisingly, the most frequent response to the questions was no! 

Further, while corralling a so-called profession at a meeting or conference to chat about possible career options at his/her company or institution is a possibility, asking the same person to take time out from their busy daily schedules to have the same discussion with you becomes increasingly difficult.

Finally, the notion that most professionals want to help others achieve career success is unrealistic and pretty much not the way things work.

As you may have guessed, I am not a big fan of informational interviews. And, I suspect that most professionals who are asked to participate are not either. Nevertheless, these types of interviews are growing in popularity and apparently are de rigueur. That said, the purpose of this post is help folks who participate in informational interviews to manage expectations. To that end; will an informational interview result in the possibility of getting hired at a particular company—probably not. Will it provide jobseekers with valuable new insights and information about possible career choices? Maybe; if you ask the right questions. Will the interview be worth the time that you took out of your day to participate? Possibly, but you don’t know until you try it. 

For those of you who may still be interested in informational interviews, I found an article that provides readers with a step-by-step approach to informational interviews (see below)

Open a Door With an Informational Interview

What is an informational interview? An informational interview is a meeting between you and a professional. The purpose is to help define your career options or research a company where you want to work. It is NOT a job interview. Do not expect anyone to make you an offer.
What is my role? You are the interviewer. Prepare plenty of questions to keep the conversation moving.  Include questions about the occupation or business, but ask about other things too: Do they enjoy their work? How do they spend their day? Open-ended questions are best to avoid yes or no answers. See a list of sample informational interview questions.

How do I set one up?

1. Find people ask everyone you know for potential contacts in a field, company or job that piques your interest.
2. Make contact Pick up the phone and make contact. Possible phone script:

"Mrs. Smith, Brad Johnson suggested I speak with you. My name is Steven Olson and I am interested in the ________ field. I could use advice from someone who is in this field. Do you have any time this week when I could meet with you? I know you're busy, so I only need about 15 minutes of your time. I would really like to learn more about your company and the ________ field from someone like you."

What else should I remember?

• If meeting in person, dress and act professionally.
• Make a good impression. This person may provide additional leads or referrals that could lead to a job.
• Keep it short. Limit your initial interview to 15 to 30 minutes based on how the conversation is going.
• Feel free to schedule the interview with someone without hiring power. They often know more about day-to-day activities and have more specific information for you.
• End the interview with an action plan. Ask the interviewee if you can contact him or her again.
• Remember to send a thank-you note after your interview!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the Sanofi-Aventis/Genzyme hostile takeover saga that dragged on for almost a year). Interestingly, there have been 219 acquisitions of U.S. pharmaceutical companies in the past 12 months, with an average disclosed price of $153.7 million and an average premium of 44 percent!

Late yesterday, Valeant Pharmaceuticals announced plans for a hostile takeover bid for Cephalon, a 24 year old Pennsylvania-based biopharmaceutical company with eight products on the US market and more than 100 products worldwide. The takeover bid became “hostile” after Cephalon’s management team rejected earlier proposals.

Cephalon’s main focus is on nervous system disorders, pain and cancers. It is one of the world’s top 10 and most profitable biopharmaceutical companies. The company had revenues of $2.81 billion last year from sales of its narcolepsy treatment Provigil ($1.2 billion) and its leukemia treatment Treanda ($393 million). Also, according to the Cephalon website, there are several oncology products (lung, melanoma and solid tumors) in its development pipeline. In 2010 Cephalon announced seven acquisitions many of which were intended to bolster its oncology expertise.

Valeant Pharmaceuticals International, long a struggling speciality pharma company, merged with Biovail Corporation late last year and re-emerged as a re-invented company with substantial financial resources at its disposal. Prior to the Biovail merger, Valeant had a long history of acquiring smaller companies to bolster its R&D capability and its flagging drug development pipeline. The new company specializes in neurology and dermatology and has a diverse product portfolio that consists of branded pharmaceuticals, branded generics and over-the-counter medicines. In 2009, its revenues were $1.65 billion and 2010 revenues (to be released) are likely to exceed $2.0 billion. 

According to Bloomberg News, Valeant has offered to buy Cephalon for $5.7 billion in cash. Under terms of the offer, Valeant would pay $73 a share in cash; a 24 percent premium on Cephalon’s Tuesday closing stock price or a 29 percent premium to company’s 30 day trading average. Not surprisingly Cephalon executives summarily rejected the offer as “too low.” Several financial analysts concur with Cephalon and contend that the $73 per share cash offer undervalues the company’s true worth. Valeant and Cephalon are main competitors in the oncology and neurology markets.

Unlike the Sanofi/Genzyme bid, where it was clear at the outset to most observers that Sanofi would ultimately prevail, it isn’t clear whether or not Valeant will be successful in its attempt for Cephalon. While Cephalon has had its share of trouble with FDA over the past few years (for a variety of infractions including off-label marketing of Provigil), the company is in much better shape than Genzyme and the current management team has more resources at its disposable to ward off Valeant’s hostile takeover bid.

The downside of a Valeant-Cephalon merger would be job loss for many current Cephalon employees. This is because Valeant’s bid for Cephalon appears to be a “pipeline grab” rather than an R&D play. Typically, these types of acquisitions result in reorganization and downsizing of personnel because of duplication of effort. Only time will tell if Valeant will prevail.

Stay tuned for more late breaking news!

Until next time...

Good Luck and Good Job Hunting!!!

 

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Internships are rapidly becoming a “must have” item for scientists who are interested in landing jobs at pharmaceutical, biotechnology and medical devices companies. Further, these days, internships are considered by to be a legitimate substitute for the “previous industrial experience” requirements that most entry level scientists must have to be hired.

Most companies offer internships because it allows them to evaluate a person’s ability and possible employability without having to pay a high salary or provide them with benefits. In essence, a company is test driving a potential new hire before it decides to buy. To that end, if an intern doesn’t pass muster or fit in with the prevailing corporate environment, then the company is not obliged to do anything except to thank him/her for a job well done and move on to the next intern! 

Unfortunately, while many life sciences companies think internship experience is a great idea, there is no dedicated repository or database for life sciences internship opportunities. Further, many companies that have formal internship programs don’t highly promote or advertise them (this makes no sense to me but then again I am not running a life sciences company).

To address the growing popularity of internships, a couple of websites, Internships.com and the Internqueen.com have appeared in recent years. These sites list and promote internship opportunities and help to match internship seekers with the right company. Also, both sites offer tips and insights for those seeking internship opportunities. Although neither of website is dedicated to internship possibilities for life scientists, Internships.com is actively trying to build its capability and reach for the life sciences industry.

For more detailed information about internships an article by Phyllis Korkki, author of the NY Times “The Search” column entitled The Internship as Inside Track” is worth a quick read.

Finally, please check out Internships.com and let me know what you think. Also, tell them that BioJobBlog sent you!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
4. Prioritize by first addressing the conditions that will most likely affect product quality.
5. Outline how and when each deficiency will be corrected.
6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
8. Keep in mind that there is a formal process available for you to dispute the findings.
9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time....

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)

 

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While video may be losing some of its “newness" and cache in social media circles, it continues to grow and has become a mainstay of networking platforms like Facebook, Twitter, and of course YouTube!  Despite its popularity in most industries, the life sciences industry continues to eschew its use. The reasons for this are not clear but it is counter intuitive given the billions of dollars the pharmaceutical and biotechnology companies annually invest in direct-to-consumer advertising. 

Several big pharma companies, most notably Johnson & Johnson, have attempted to increase the use of video to connect with its stakeholders but its efforts haven’t yield much of an ROI. I suspect that most industry insiders will tell you that the main reason why video is not routinely used is the lack of regulatory guidelines guiding its use on social media platforms. While this is a facile explanation, the existing regulatory guidelines for direct-to-consumer television advertising certainly apply to video!

In a post today on the EyeonFDA blog, Mark Senak offers a variety of ways in which life sciences companies can leverage video to their advantage to promote good will among shareholders and stakeholders alike. His ideas make sense and are very much within the regulatory guidelines for direct-to-consumer advertising. Whether or not direct-to-consumer advertising is a good thing is a topic for another post!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Medtronic one of the world’s largest medical devices manufacturer earlier this week announced that it will cut its workforce by 5 percent which translates into 1,500 to 2,000 fewer jobs. Most of the cuts will come from the company’s struggling external heart defibrillators unit (Physio-Controls) which it would like to sell. Revenues from pacemakers and defibrillators, Medtronic’s largest selling products, fell 2 percent in the last quarter. 

In a statement, the Minneapolis-based Medtronics will cut 4 percent to 5 percent of its employees with voluntary programs, retirements and layoffs. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Project management (PM) is growing as a career option for life scientists. This is mainly because life sciences companies have begun to realize that team projects with professionally trained PMs at the helm (as compared with research scientists lacking in PM skills) are conducted more efficiently and cost effectively.

Because of the “newness” of the PM option, in the life sciences industry, there is no formal training or a direct pathway to become a PM. However, Bruce Fieggen, Vice President of Project Management and Training at QPharma— who has over 25 years of experience as a project manager (and trainer) in the life sciences industry—offers some ideas and insights on how to become a PM.

On Becoming a Project Manager in the Life Sciences Industry

By Bruce Fieggen

By now you have probably worked as a team memberon several projects and may be thinking that a career in project management may be right for you. So, how does one become a project manager in the life sciences industry?

The best first step is to obtain some formal training in project management (PM). There are many courses designed as evening programs, university classes or three day workshops. You can take them in person or online. While some of these training options may not be as comprehensive as others, it will help interested persons to determine whether or not a career in project management may be right for them. Once you have obtained some formal training, the next step is to take an honest look at your personality. Are you an extremely introverted person who feels uncomfortable talking with others on a regular basis? Do you fear speaking in public? Are you a good listener?  

If the answers to these questions are a resounding “no” or maybe, then PM may not be a good career choice. However, if the answers are yes, then volunteer to run a small project or a sub-project of a larger team effort. Be prepared to learn from the mistakes that you undoubtedly you will make. And, also be prepared to do other people’s work in order to get your small project finished on time! Once you have exhibited some aptitude as a PM, you may be asked to take on larger projects and if you are successful you may be on track for a lifelong career as a PM.

People become successful project managers from almost any discipline or field. In my almost 25 years as a PM (and PM trainer), I have seen PMs hail from jobs in R&D, manufacturing, marketing, purchasing, engineering, quality, and regulatory affairs. No particular group produces better PMs than another. That said, all successful PMs:

• Are great communicators and know how to listen
• Know the process of managing projects and can show you the schedule, scope and budget at any time
• Are rarely at the extreme introverted end of the extraversion – introversion continuum
• Understand how to motivate people to work for them when they don’t actually report to them
• Implicitly understand that the project (not their egos or kudos that they may receive), takes precedent over everything else

To learn more about a possible career as a PM, I highly recommend that you join PMI.org and attend monthly meetings at a local PMI chapter. Network with fellow PMs and learn from them. Pretty soon you’ll be in the thick of things and understand what being a PM is all about! 

Please check out my Round Table Project Management blog for additional information and feel free to contact me.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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The life sciences industry is all a-Twitter (sorry) about social media and its implications for future business opportunities. Nevertheless, despite the obvious “upside” of social media, as is always the case in the pharmaceutical industry, most companies don’t want to be the first to do anything innovative or novel (go figure).  

Obviously, there are many risks associated with being first in anything. But, the aversion to being first in the industry to “rock the boat” is more pronounced in the pharmaceutical industry than in most others. That said, companies like Novo Nordisk (the first successful promotional product Twitter campaign), Johnson and Johnson ( the first company to blog) and Boehringer Ingelheim (using Twitter for conversational purposes not just a corporate news feed) at various times, dared to go where no company has gone before with the social media experiment. And, despite the apprehension and almost palpable trepidation exhibited by these companies, no overt consequences have resulted from the bold moves made by these social media pioneers. It now appears that there is another new benchmark for companies involved in the pharmaceutical social media experiment; the first ever sponsored pharma Twitter Chat held by @AstraZenecaUS.

This event was first reported (as far as I can tell) by Mark Senak, the author of the informative EyeonFDA blog and one of the leading pharmaceutical social media watchdogs. The Twitter Chat (under the hash tag #rxsave) was held by @AstraZeneca to discuss with its followers ways in which patients can save money on prescription drugs. While I didn’t participate in this somewhat paradoxical chat —a prescription drug companies discussing ways in which patients may save money on their expensive prescription drugs? —it does demonstrate willingness on AstraZeneca’s part to interact with prospective customers in a meaningful way to help them overcome financial barriers to access to potentially life- altering or-saving prescription drugs!

Although there are still no regulatory guidelines governing the use of social media by life sciences companies, the willingness of @AstraZenecaUS to put itself on the line is very refreshing. In my opinion, it is an important first step to help to “humanize” pharmaceutical companies. Also, it demonstrates a willingness by a pharmaceutical company to provide help to persons who perhaps cannot afford or are struggling to gain access to the prescription drugs that they need!

Hat tip and kudos to @AstraZenecaUS!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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According to a "mention" today on the Pharmalot blog, a French newspaper reportedly learned that Sanofi-Aventis may be spending up to $1 billion this year to acquire up to four ophthalmology companies. Although the companies were not identified, three of the companies that Sanofi is eying (pun intended) are located in the US and the fourth is reportedly in Israel.

An aging global population coupled with the diabetes epidemic plaguing the US and several other Western countries suggest that ophthalmology drugs may be a good bet for the future. This, coupled with the impending acquisition of Genzyme suggests that Sanofi-Aventis is trying to create somewhat of a soft landing for the company after patent expiry in early 2012 of Plavix, its major money maker.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.

Historically, the regulatory challenges for getting medical devices approved have always been much lower than those for garnering approval of prescription drugs, vaccines and other biological products. Since 2000, the regulations guiding regulatory approval for medical devices had grown extremely lax.  For example, there has recently been a spate of recalls for certain previously-approved devices including cardiovascular stents, implantable cardiac devices and hip replacements.

The Obama administration is attempting to restore the rigor of the approval process and some medical devices companies are extremely unhappy about it. This renewed effort has forced some devices companies to eschew the lucrative US devices market entirely in favor of European and Asian markets; mainly because they were unable to garner FDA approval for their devices. Interestingly, the companies that are complaining the loudest are start ups rather than established medical devices companies. Their main complaints are the ever-increasing size of the clinical trials and length of time it takes to win regulatory approval for their products. Not surprisingly, these complaints are mostly driven by financial pressures at the start ups. Because of the recession, many of the venture capitalists who backed these companies have less money to invest and demand quicker and higher returns on their investments. Consequently, many of the star tups are under capitalized and simply don’t have the financial resources to stay in business and wait for FDA approval. While I understand their business pressures and urgency, winning FDA approval is suppose to be about safety and efficacy not about ROI. Maybe start up devices companies experiencing these difficulties ought to retool or reinvent their business plans!

To be clear, FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510(k) clearance (less stringent than PMA and used for most devices) rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seem to be getting tougher than in the recent past. But, if that helps to improve efficacy and patient safety than I don’t necessarily think that it is such a bad thing. And as Stephen Oesterle, MD senior vice president for medicine and technology at Medtronic (one of the world’s largest medical devices companies) aptly said in a recent NY Times article “The FDA is asking for larger trials, more thoughtful trials, all in the interest of the American public.”

Until next time...

Good Luck and Good Job Hunting!!!!

 

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There is no question that DNA, genome sequencing and personalized medicine are on their way to becoming part of the American lexicon. While most Americans haven’t a clue as to what these words mean, many have jumped on the “DNA bandwagon” because of television shows like CSI and its derivatives and high profile genetic information companies like 23 and Me, which was co-founded by Anne Wojcicki a Yale undergraduate biology major and wife of Google founder Sergey Brin.

Countless numbers of Americans have sent DNA samples to be analyzed by 23 and Me and other genetic information companies to learn about their ancestry and possible health implications contained in their genetic codes. Although the technologies used by these companies may not be ready for prime time-use for personalized medicine purposes, they are scientifically sound and relevant. Imagine my surprise when I read about a company called DNA11 that promises to create customized art from a person’s DNA. Yup, you heard me correctly—a customized DNA portrait! 

Here is how it works. Customers send a cheek swab (DNA sample) to the company and they sequence it. Then, a personalized DNA portrait is constructed from the code. Clients get to choose the color and size of the portrait and can also elect to have up to four person’s DNA added to it! And the best part is that it only costs $199 (starting price)! Of course, DNA samples are marked with anonymous codes and are supposedly destroyed after portraits are rendered.

DNA 11 is the brain child of Nazim Ahmed a former DNA imaging salesperson and Adrian Salamunovic a web designer. I have to admit that I thought the idea was a cool one! But, then again, I am a geeky scientist and the transformation of science into art is an intriguing proposition! Also, if positioned correctly, DNA11 could help to promote scientific literacy in the US.

The company has been featured in the New York Times, Wired Magazine and others on “The View” CNBC and the Discovery Channel. Moreover, both Nazim and Adrian have reportedly made millions and their products were recently featured on a recent CSI episode. Recently, the company announced that a portion of its revenue will be donated to charity. Nevertheless, I can’t imagine that, these days, most lay people have enough disposable income on hand to spend it on a less-than-useful DNA portrait. That said, I have been known to be wrong in the past. And, I have learned over the years that anything is possible in America--not that there is anything wrong with that!

Until next time...

Good Luck and Good Genetic Profiling!!!!!!!

 

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The recent article published in the NY Times about the decline of high school student participation in science fairs resulted in many letters to the editor. Many of them were from concerned citizens and a few were from university researchers decrying the lack of government funding for research and the funding of sports over science programs. Another railed against the Bush’s Administration’s poorly crafted and ill-advised No Child Left Behind Act. However, there was one letter that surprised me. It was written by John P. Holdren, President Obama’s science and technology adviser (see below)

To the Editor:

Your article points to deep budget challenges that many school districts are facing and problems with the Bush administration’s No Child Left Behind law.

But it does not mention much of the Obama administration’s extraordinary agenda for improving science, technology, engineering and mathematics (STEM) education in this country: for example, the commitment to prepare 100,000 new math and science teachers over the next 10 years, the $4 billion Race to the Top program’s support for innovation in teaching these important subjects, and the administration’s blueprint for updating the Elementary and Secondary Education Act this year.

Recognizing that government alone cannot be the answer, moreover, the president has also called upon the business community, foundations, professional societies and others to do more. Already, the president’s “Educate to Innovate” campaign has attracted more than $700 million in nongovernmental financial and in-kind support for science and math programs.

And more than 100 chief executives have responded to the president’s “all hands on deck” call to action by launching “Change the Equation,” an unprecedented program to scale up effective models for improving STEM education.

John P. Holdren
Washington, Feb. 7, 2011

The writer is President Obama’s science and technology adviser.

What surprised me about the letter is that it took an article critical of the Obama Administration’s commitment to science education to provide the American public (at least part of it) with some insight into the government’s recognition of the problem and steps that it is taking to help to correct it. Perhaps the Obama administration needs to be a bit more proactive and publicly-vocal about its plans to improve American STEM education. This would go a long way to assuage some of the concerns about America's waning global competitiveness in science and technology.

Like Dr. Holdren, I believe that government alone cannot be the answer and American corporations must get actively involved by providing ideas on how to improve American science education and the financial support to implement them. While the CEO-endorsed program “Change the Equation” sounds great on paper, it is time for those CEOs to actually step up and do something about the problem. Many of these same CEOs have been complaining for decades about the lack of STEM preparedness of the American workforce. As somebody once said “Talk is cheap and actions speak louder than words!”

Until next time...

Good Luck and Good Teaching!!!!

 

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Believe it or not, I was interviewed by Karl Schmieder of Bridge 6, a digital healthcare marketing firm about the genesis of BioCrowd and why online networking is important for bioprofessionals and healthcare providers. This is a first for me and it signals that online networking for life scientists and other bioprofessionals may actually be starting to catch on. You can read the entire interview by clicking here.

While most other sites like Benchfly, Epernicus, Labspaces, ResearchGate and others cater almost exclusively to scientists, BioCrowd was created as an online networking and career development site for ALL bioprofessionals including those involved with marketing, manufacturing, publishing, writing, fun raising etc. We want prospective BioCrowd members to think of the community as a “one-stop-shopping” site for life sciences professionals who want to network, advance a career or even start  up a biotechnology company! Check us out!

Until next time...

Good Luck and Good Job Hunting (I hope to see you at BioCrowd!)

 

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According to a post on the Pharmalot Blog, Abbott Laboratories today announced that it will eliminate 1,900 jobs or six percent of its workforce. The company cited its thinning pipeline and the current challenging regulatory environment for the corporate reorganization and downsizing. In other words, we are having trouble getting our new drugs approved and we can’t afford to continue to pay people’s salaries and benefits who aren’t delivering for us. The Pharmalot post didn’t provide specifics on the layoffs.  However, Lisa Madden a Delta  Pharma Recruiter and BioCrowd member  sent me a message and told me that 1,000 of the layed off workers were onsite employees and the remaining 900 were sales reps

Like it or not, this is the new reality for life sciences R&D types, So, if I were a  graduate student or postdoc considering a career in the life sciences industry, I highly recommend a well developed and carefully thought out “Plan B.”

Until next time,

Good Luck and Good Job Hunting!!!!!

 

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In press release today, Merck & Co disclosed that it reduced the size of its global sales force by 12 percent in 2010. Ken Frazier, Merck’s newly appointed CEO, pointed out that cuts in sales force sizes in developed markets like the US and Europe reached almost 30 percent. Yet, despite these cuts, Merck reported that it was able to boost sales in its vaccine and pharmaceutical business units.

Merck, like most other big pharmaceutical companies, have drastically reduced the sizes of their sales forces in recent years. The cuts have been attributed to higher than expected product attrition rates, product recalls and changes in physician preferences. It appears that many physicians grew tired of repeated visits by multiple reps after they were no longer allowed to give gifts or buy lunches for physician office staff. Further, many industry analysts contend that the advent of web-based marketing, social media and medical reimbursement overhaul (doctors no longer have time for reps) have largely rendered most pharmaceutical sales reps obsolete!

Other factors contributing to the recent demise of pharma reps are thin drug development pipelines, tougher regulatory standards for drug approval and impending patent cliffs (generic encroachment) for many blockbuster small molecule drugs. Put simply, fewer drugs require fewer people to sell them.

I think the death knell for pharma reps may be a bit premature. Many physicians find that well trained and informed sales rep can be a great resource and helpful to their practices.  Nevertheless, looking on the bright side, there is a growing need for sales reps that possess the background and training to sell biotechnology products! That said, unemployed pharma reps may want to consider going back to school to get some biotechnology training. This training is frequently available at local community colleges and four year colleges and universities and online.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Over the past few years, life sciences companies have shed over 200,000 jobs. Unfortunately, downsizing at some of these companies may not be over yet. Nevertheless, companies are always looking to recruit new talent to keep up with normal job turnover rates or to replace highly specialized employees whose skills sets are essential to successfully running the business. Because many of these former life sciences employees possessed special or arcane talents and skill sets, advertising for their replacements using conventional methods like job boards and print ad advertising have historically met with limited success. The advent of social media platforms like Facebook and Twitter have prompted HR professionals and hiring managers at some life sciences companies to test social media as a recruitment tool.

While Facebook may come to mind as the most likely social media tool for this purpose, it isn’t! This is because Facebook is primarily a social, not a professional network like LinkedIn or BioCrowd. Further, despite Facebook’s gargantuan size, the lack of real time interaction coupled with the sheer volume of updates, ads, activities and games at the site render it largely ineffective as a job advertising or recruiting tool.

Twitter, on the other hand, is an ideal medium to advertise jobs and attract new talent. This is because information that is broadcasted on Twitter has the potential to reaches large numbers of persons very rapidly. Moreover, regular Twitter users pay attention to activity on their feeds and like to “retweet” information that they find useful or helpful to their followers. Finally, many Twitter users regularly cull their follower lists to more accurately reflect their interests which suggest that the quality/focus of most follower lists on Twitter far surpasses that of friend networks on Facebook. For example, I manage the @BioCrowd Twitter feed. To that end, I decide who BioCrowd follows and wants to follow. And, not surprisingly, I only follow or allow individuals to follow BioCrowd  who are interested or work in the life sciences. Currently, BioCrowd has over 1,300 followers, all of whom work or are involved in some aspect of the life sciences industry. Because, I have intentionally created a highly specialized network of life sciences professionals, the likelihood of a prospective employer finding a “right fit” candidate by tweeting a job ad to the BioCrowd network greatly increases. Further, the ability of Twitter users to direct the job tweet to specific followers or retweet it preserves the longevity of the ad and improves its effectiveness. And, perhaps the best thing about using Twitter as a job announcement platform is that it is free!

The use of social media as a recruiting and retention tool by Fortune 500 companies like American Express, Best Buy and others is not new. However, its use as a recruitment platform by life sciences companies is very new to the life sciences companies. As many you may know, the life sciences industry has been slow to adopt the use of social media. Nevertheless, several companies like Merck (@merckcareers1) and AstraZeneca (@JoinAstraZeneca and @AstraZeneca Jobs) have decided to boldly go where no other pharmaceutical companies have gone before and are beginning to experiment with Twitter as a recruiting tool.  

About a year ago, I wrote a post that suggested that social media would be an ideal recruitment and retention tool for most life sciences companies. The fact that a couple of companies are testing this idea suggests that my idea may be a good one! 

If you know of other companies using Twitter to recruit new employees, please leave a comment or contact me.

Until next time...

Good Luck and Good Job Hunting (@BioCrowd)

 

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Twitter, for all intents and purposes, is arguably the hottest new tool to hit the social media scene since well.....errrrrrr....Facebook (are there really any others?). That said, everyone who is anybody has jumped on the Twitter bandwagon whether or not using Twitter has any positive or negative effects for its users. Nevertheless, insightful social media analysts like Mark Senak, author of the fabulous EyeonFDA blog, frequently attempt to assess the overall effectiveness of social media tools like Twitter on specific industries—in this case, the life sciences industry.

To make sense of the relative effectiveness (influence) of Twitter use by life sciences companies, Mark used a Twitter and Facebook assessment tool known as KLOUT.  KLOUT generates a “score” for individual Twitter feeds based on a combination of 35 different variables. The resultant scores fall into a range from 1-100 with a higher score indicating a wider range of influence. 

Not surprisingly, Mark’s analysis revealed that Twitter feeds sponsored by Roche (Roche News, 52), Novartis (Novartis, 52) and Pfizer (Pfizer News, 51), three of the world’s largest pharmaceutical companies had the most KLOUT. Not far behind were Lilly (Lillypad, 47), Pfizer (PfizerMexico), AstraZeneca (AstraZeneca, 45) and Amgen (Amgen, 44). Other companies that warrant honorable mention include: Genentech (GenentechNews, 40), Bristol-Myers Squibb (BMSNews, 40), Johnson & Johnson (JNJStories, 40) and Vertex Pharmaceuticals (VertexPharma, 39).

Interestingly, many companies sponsor multiple Twitter feeds. For example, Sanofi Aventis AstraZeneca, Bayer, Boehringer Ingelheim and Novartis have five, JNJ has 4 and Roche, Baxter and Amgen have 3. It isn’t clear to me why companies would want to have more than one Twitter feed; doesn’t that dilute corporate messaging? But, then again, what do I know?  I am not a marketing or PR guy!

So, what does this all mean? As far as I can tell—not much! The only conclusion that I can draw from all of this is that Twitter, the most recent successful addition to the social media armamentarium, is no longer new but here to stay!

Until next time...

Good Luck and Good Tweeting!!!!!!!

 

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In a first-of-its-kind study, researchers at the Public Citizen’s Health Research Group tracked the civil and criminal financial penalties levied against the pharmaceutical industry for wrongdoing over the past 20 years. 

The main findings of the study revealed:

1. Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
2. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
3. The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
4. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
5. Former pharmaceutical company employees and other “whistleblowers” have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

The companies, their missteps and the fines imposed are shown below:

The authors conclude:

"Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry."

Interestingly, about a month ago officials at the US Food and Drug Administration signaled that were willing to prosecute company executives to the fullest extent possible (including criminal prosecution) to reduce the incidence of fraud, off-label marketing and manufacturing violations that have become commonplace in the pharmaceutical industry in the past five years.

Until next time....

Good Luck and Good Job Hunting!!!!

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It is no secret that Sanofi-Aventis is facing a steep “patent cliff” in 2013 when some of its top selling drugs, most notably Plavix, will lose patent protection. Some analysts contend that the company can lose as much as a quarter of its annual revenue because of generic encroachment on blockbuster brands. Sanofi is narrowing its business to three areas -- diabetes, heart problems, and cancer -- and is seeking partnerships and acquisitions.

This past June, Sanofi inked a $398 million deal with US-based Ascenta Therapeutics to gain access to two experimental cancer drugs that are in preclinical development. Later that month, the company purchased TargeGen a privately held US biopharmaceutical company focusing on oncology R&D. Two months later, Sanofi announced that it had entered into a partnership with the Belfer Institute of Applied Cancer Science (part of the Dana Farber Cancer Institute) to gain access to additional experimental cancer treatments.

Today, Sanofi announced that it had reached an agreement with Germany-based  Merck KGaA to jointly study experimental cancer treatments. Both companies Merck will conduct early stage human trials of Merck’s MSC1936369B and Sanofi’s SAR245409 and SAR245408 experimental drugs. Under the terms of the agreement, each company will carry out an early-stage dosing test of the drug candidates. Sanofi will be granted a license to study the safety and effectiveness of the Merck compound when used with SAR245408. Merck will be given a license to work with Sanofi’s other medicine to study its use in combination with its experimental compound. Financial terms of the deal were not disclosed.

Yesterday, Sanofi announced that it had signed an agreement with Oxford University to conduct multi-phase clinical and translational research in oncology with INDOX, a network of cancer research centres established across India in partnership with the university's Institute of Cancer Medicine five years ago. According to the terms of the agreement Sanofi-Aventis has agreed to provide financial support to Oxford University in managing the INDOX network of eight cancer research centres across India. 

Based on this spate of activity over the past six months it would appear that Sanofi is executing its new long term strategic plan. Stay tuned for more news!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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A new report released by Deloitte LLP entitled “To Friend or Not? New Insights about Social Networks in the Life Sciences Industry” indicates that roughly 65 percent of survey life sciences company professionals say their companies use or plan on using social networks in some capacity at a corporate level. Interestingly, 35 percent of those surveyed have no plans to do so!

Survey respondents say the lack of Food and Drug Administration (FDA) guidelines, consumer privacy concerns and a lack of a clearly demonstrated return on investment are the top three hurdles to widespread adoption of social networking platforms.

Even after the FDA guidelines for social networking are issued (who knows when that will be?), more than half (53 percent) of respondents still expect a significant amount of confusion around how life sciences companies can engage with social networks. Forty-six of companies that already use social networking tools will continue to use them but will not increase investment until the FDA provides guidance.

More than one-third of respondents (38 percent) are waiting for the FDA to issue guidance before making any investment. Nearly three in 10 respondents (28 percent) said their companies are waiting to see what ROI other companies get. However, the majority (73 percent) expect the budget allocated for social networking will increase over the next three years.

Additional findings from the report that surveyed marketing/brand management professionals include:

• Approximately 44 percent have an informal strategy for social networking that is not documented and/or fully supported by leadership, while 32 percent have no strategy at all.
• Survey respondents use social networking to disseminate information (51 percent), proactively seek information (42 percent), or to react or respond to pertinent information posted on an online social network (23 percent).
• One in five (20 percent) are indifferent to using social networking.

One of the authors of the study suggested that “Our survey findings demonstrate that the bulk of the use for social networking now is geared largely towards marketing. However, there are additional strategic applications beyond pure marketing still to evolve, such as conducting market research cheaper and faster; working with foundations to mobilize patients; improving peer-to-peer education through cost-effective medical education; determining the right patient reported outcomes; and providing data to help speed-up clinical trials.”

I have long contended that the least likely application of social media in the life sciences industry would be for promotional and marketing purposes. While this previously was a minority position, Jonathan Richmond, who authors the popular social media and marketing blog “Dose of Digital”, finally agreed with me in a recent post, entitled “Social Media is Not for Advertising Pharma Brands.”

Unfortunately, much of the early conversations surrounding the use of social media in the life sciences industry were promulgated by pharmaceutical marketing consultants and product brand managers. The early emphasis on promotional use caused many pharma executives to head for their command bunkers at the mere mention of social media (mainly because of its possible regulatory implications). Luckily, less financially-motivated persons began to join the conversation and successfully floated ideas about less regulatory risky uses of social media. Interestingly, the promotional use of social media in the life sciences industry is no longer the main topic of conversations at most pharma and social media conferences these days.

It appears that most life sciences companies are willing to concede that social media is not a fad and not going away anytime soon. As the old adage goes “You gotta be in it to win it.”

Until next time...

Good Lucking and Good Surfing!!!!!

 

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What a difference six months can make in the fast moving world of the social web! At last May’s Advanced Learning Institute’s conference on “Social Media for Pharma” there was a lot of anxiety, hand wringing and concern about the future of social media in the life sciences industry. 

Things were much different at “Social Media for Pharma” (also sponsored by the Advance Learning Institute) held earlier this week in Manhattan. Like last May’s meeting, there was still much speculation about when the US Food and Drug Administration (FDA) may provide the much awaited regulatory guidance on the use of social media for promotional purposes in the pharmaceutical industry. And, despite a presentation by FDA representatives at the meeting—that somewhat paradoxically described how the agency was using social media tools like Twitter, YouTube and Facebook to better educate and inform the American public about its activities and services —there were no hints about when the agency may issuing that guidance. Nevertheless, the number of pharma and biotechnology companies that have decided to “take the plunge into the social media pool” has grown substantially since last May. In fact, I got the sense that many of the conference participants were beginning to believe that implementing social media strategies was possible even if the agency fails to issue the long awaited guidance!

Generally speaking, there was a growing consensus at the meeting that the use of social media for promotional purposes—specifically to bolster sales of approved and marketed drugs and devices—may not be its best use. Several presentations, most notably those offered by Justin Gardener and Lindsey Hart from Advanced BioHealing, Inc and Jenny Keeney from Astellas Pharma US, Inc showed how social media can be used by life sciences companies to improve healthcare outcomes for patients and promote science education to improve the public understanding of science. Nancy Buono Cartwright from Kaiser Permanente gave a great talk on how to use social media to enhance corporate communication and employee participation and retention. 

A panel discussion featuring Dennis Urbaniak, Sanofi Aventis, Cynthia Phillips, Millennium Pharmaceuticals, Inc and Justin Gardner, Advanced BioHealing, Inc and lead by John Mack aka the Pharma Guy was insightful and extremely illuminating regarding pharma’s changing attitudes toward social media. All of the panelists agreed that the drug industry is in transition and that now may be the time to try new things to get back to addressing unmet medical and patient needs. More importantly, Dennis Urbaniak stressed that pharma must begin to listen to what patients and stakeholders want rather than dictating or imposing “its” ideas and products on them. And, that it is apparent that social media provides an ideal vehicle to accomplish that goal.

Finally, Doug Levy, a compliance lawyer and Executive Director of Communications and Public Affairs Columbia Medical Center, gave an inspiring talk on how social media is no different than traditional modes of communication and that best practices already exist whether or not FDA ever issues any additional guidance on the topic! It appears that it is no longer a question of “if” but “when” as pharma continues to warm to inevitability of social media.

Until next time...

Good Luck and Good Tweeting or Whatever Your SM Tool of Choice May Be

 

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Despite public assertions made by Novartis a mere eight days ago that it would not be eliminating thousands of jobs, the company today announced that it was eliminating 1,400 sales reps. Roughly 1,150 jobs will be cut from its primary care division—which is being consolidated into three units from four in the US—and another 250 from psychiatric and neuroscience. No jobs will be eliminated from Novartis’ headquarters in Hanover, NJ. While the job cuts announced today were not in the thousands (almost) it isn’t clear whether or not more are to come.

According to a post on today’s Pharmalot blog:

"Novartis had attempted to dampen speculation that a huge bloodletting was imminent after Roche disclosed plans to axe 4,800 jobs worldwide (back story) and, in fact, Joe Jiminez, the CEO, had written on his internal blog that news reports about big layoffs were inaccurate. Technically, the Novartis reduction is not in the thousands, but the number is still large and, essentially, confirms concerns that have been expressed over the past month at CafePharma, the online forum where reps dish the dirt (look here)."

Don’t you just love the holidays?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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During the course of my long and somewhat varied career, I have had the opportunity to work at a variety of different companies and organizations. Admittedly, while I am generally a “half-empty” kind of guy, the places where I enjoyed working the most were the ones where people treated one another with respect and management made a concerted and obvious effort to create a positive workplace environment. It didn’t matter whether I was a manager or a contract worker; I enjoyed going to work every day and I worked hard for the company. 

Unfortunately, many companies don’t understand the importance of a positive and supportive workplace. And, not surprisingly, the workplace environments and corporate cultures at these companies are toxic and destructive. They are frequently rife with dictatorial managers and nasty co-workers who are intent on sabotaging one another to “get to the top.” No one who works for these companies is happy or productive and most employees are intent on getting out when they can. However, until they leave, they are unhappy, stressed and generally miserable on a daily basis. With this in mind, it is important that these employees learn or develop skills to protect themselves against the toxic effects of a dysfunctional workplace.

To that end, Robert Sutton provides insights and ideas on how to accomplish this in an article entitled “How Bad Apples Infect the Tree” that appeared in this Sunday’s NY Times Business section.

It is definitely worth a read!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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While I typically don’t subscribe to practice of unbridled self promotion, I could not pass on the opportunity to let my readers know that BioJobBlog made the "Top 50 Blogs About Careers in Science."

Rachel Stevenson, a co-founder of Clinical Research Masters sent me a link to the list. The top 50 sites are divided among four categories 1) General Science Career Blogs, 2) Tech Career Blogs, 3) Medical Career Blogs, and 4) Academic and Research Blogs.

I have no idea how the list was constructed nor do I understand how the rankings were calculated. That said, BioJobBlog was ranked number three in the General Science Career Blogs category (see below). The two blogs ranked ahead of BioJobBlog are run by major organizations with multiple contributors. BioJobBlog is written almost entirely by me...Just sayin’

Many of the blogs on the list are useful resources and I highly recommend visiting them all.

1. Science Careers Blog: This great blog goes over career opportunities, and provides the latest news for job seekers.
2. Jobs for PhDs: This blog from phds.org offers information on available jobs for scientists. The site also has access to helpful career information.
3. BioJobBlog: You can find information about different jobs in the biological sciences.
4. ScienceBlogs: This site offers interesting commentary on scientific issues, and includes information about careers in science.
5. Science careers: This category at OITE Career Blog offers a look at different science careers, and provides tips for preparing for a science job.
6. APECS: The Association of Polar Early Career Scientists offers news and information about the career opportunities to scientists interested in polar issues.
7. Alternative Science Careers: Job openings and other resources for those looking for science careers.
8. ScienceCareerSite: Tips, news and more related to science careers.
9. American Biotechnologist: Information about careers, as well as news in science. Great tips about how you can enhance your career.
10. Society of Physics Students: This site contains great posts that can help you with career development, and includes jobs as well.
11. Careers: Physics.org offers a great look at different careers, and offers news and information about science.
12. ACS Careers: Insights into what’s available in the world of chemistry careers.
13. Career Development for Scientists: Lisa Balbes offers solid information and advice for scientists looking for tips to help their career development.
14. CENtral Science: One stop for science news, career information, and trends in science jobs. A wide variety of posts on a number of interesting subjects.
15. The Alternative Scientist: Jobs and career news related to alternative science.
16. New Scientist: Science headlines, career information, science jobs and interesting discussions.

For a complete listing of all science career development blogs, please click here.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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The fiscal year at most life sciences companies is drawing to a close, new budgets are being crafted and the holiday season is almost upon us. In years past, this time of year typically meant that it was bonus time for most pharma workers. Sadly, over the past three years bonus time has been replaced by layoff time. And, unfortunately the upcoming holiday season may not be joyous for many Pfizer and Roche employees.

Yesterday, Pfizer indicated that it may lay off up to 11,700 more employees than the 19,500 it had announced in connection with the buyout last year of Wyeth Pharmaceuticals. While Pfizer confirmed that it would be reducing its worldwide work force by more than the originally expected 19,500 the exact number remains a mystery. However, a quarterly report filed Friday with the U.S. Securities and Exchange Commission stated that Pfizer has estimated termination costs for 46,600 employees, while only 33,400 workers had actually been laid off as of Oct. 3. This appears to suggest that the company plans to reduce its work force by 11,700 more than originally announced, given that Pfizer is only 1,500 positions away from fulfilling its job-elimination pledge related to the Wyeth merger.

The additional job cuts—if they are realized—would amount to about 10 percent of Pfizer’s worldwide work force. If a reduction of that magnitude were applied to Pfizer drug-research sites in Groton and New London, which currently employ nearly 5,000 workers, about 500 jobs would be lost. The company in January 2009 announced that cuts would total 15 percent of the combined Pfizer and Wyeth work force. At the time, the combined work force numbered about 130,000; the latest official figure places that number at 111,500.

In other news, Roche today announced plans to cut 4,800 jobs, or 6 percent of its worldwide workforce of 82,000. Today’s announcement confirms the news leak three months ago (reported by the Pharmalot Blog) which suggested that job cuts would be likely during the fall.

According to today’s press release, technical operations activities will be reorganized in California, Mannheim, Germany and various other sites, resulting in the elimination of 750 jobs. The company also intends to sell sites in Florence, South Carolina and Boulder, Colorado; shedding an additional 600 jobs. About 1,200 jobs will be cut in the North American commercial operations, mainly in Roche’s primary-care business, while 700 positions will be lost in commercial operations in Europe.

R&D will also be affected. The company will discontinue activities in research and early development in RNA interference in Kulmbach, Germany, Nutley, New Jersey, and Madison, Wisconsin. Also, there are plans to reorganize other operations at these sites which will eliminate another 600 jobs.

Until next time...

Good Luck and Good Job Hunting (are there any left?)!!!!

 

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Yesterday, Novartis, one of the world’s largest pharmaceutical company announced that it would double the size of a planned expansion of its R&D headquarters in Cambridge MA and add 200 to 300 new employees.

Not to be outdone, Teva, the world’s largest generic drug manufacturer, today announced that it would create 200 jobs at a distribution facility it plans to open in Northeast Philadelphia.

According to a press release, the $295 million project will create more than 200 jobs within three years and retain more than 200 existing positions. It would appear that cash-rich pharmaceutical and generic drug manufacturers are beginning to realize that investments in infrastructure are likely to be important as the pharmaceutical sector continues to undergo a transformation. Also, it is likely that they are running out of acquisition targets and have to spend some of their excess cash for tax purposes (I know pretty cynical but what can I say) In any event, this is good news for unemployed former pharmaceutical employee and also for the American economy!

Until next time...

Good Luck and Good Job Hunting

(Check out Philly; it's not as nice as Cambridge but a job is a job!)

 

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“Unpleasant personality traits are almost required of young entrepreneurs trying to build something lasting. It requires tremendous arrogance to believe that their idea is better than anyone else’s. They need to be immensely selfish, putting their fragile creation ahead of everything else including important relationships. And, they have to be ruthless, tossing overboard friends who were once useful and no longer are.”

—Joe Nocera, New York Times commenting on the success of Facebook founder Mark Zuckerberg.

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While a report released today indicated that the pharmaceutical market is expected to grow to about $800 billion by 2011—a 5 to 7 percent increase—pharmaceutical companies shed another 6,069 jobs in September according to the outsourcing firm Challenger, Gray & Christmas. This is compared to only 200 pharmaceutical employees who were given pink slips in August. Despite a lull this summer, it appears that pharma companies are ramping up again to layoff large numbers of employees by year’s end.

Previously, industry analysts were predicting that job losses in the pharmaceutical sector would be less than last year when 58,583 employees were shown the door. However, at the current pace—43,334 jobs lost so far—the total number of pharma jobs lost in 2010 may match or surpass the losses in 2009. This is because pharma budgets for the upcoming fiscal year are prepared in the fall and the real bottom lines are not known until the holiday season is upon us. Consequently, pharma has a nasty habit of announcing layoffs during the holiday season (nice huh?)

To date, Abbott Laboratories, Bristol-Myers Squibb, Endo Pharmaceuticals, Lundbeck, Lonza, and Johnson & Johnson have all announced plans to reorganize and downsize. It is anyone’s guess which companies may follow suit.

Unfortunately, it is tough to be in the life sciences business these days; unless of course you live in China, India, Eastern Europe and Latin America! Alternatively, it may not be a bad idea to relocate!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 

Despite the fact that off label marketing is illegal, many big pharma companies knowingly and willfully engaged in the practice. Luckily, the Obama administration has reinvigorated and restored the regulatory powers at the agency and FDA is now aggressively investigating and punishing companies that had promoted off-label use of their products over the last decade.

The New York Times today reported that Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases. The company was fined $422 million settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs. 

According to the article, the five other drugs involved in the civil settlement are Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

It is important to make a distinction between the practices of off-label drug use and off label marketing. As many of you may know, licensed US physicians are allowed to prescribe any FDA-approved drugs if they believe that their use will benefit patients. This is off-label drug use. However, in contrast, it is illegal for companies to actively promote or market approved drugs for therapeutic indications for which they have not received regulatory approval. This is off-label marketing and a strategy that has been used by companies to increase sales of approved products without having to spend money on expensive clinical trials that are required to prove safety and efficacy for a new drug to gain regulatory approval. While this may be a backdoor strategy for companies to boost product sales, it clearly puts patients at risk because the actual safety and efficacy for the indications has not been adequately tested and proven.

Many drug makers have been critical of FDA’s increase scrutiny of drug safety and have argued that it has negatively impacted the regulatory approval rates of new experimental medicines. While this may be troubling to many pharmaceutical executives, the FDA was created to insure that all approved drugs are safe and effective and the risk to Americans who use them is minimal. In other words, the agency is simply doing its job—something it was prevented from doing for the past eight years!

Until next time,

Good Luck and Good Job Hunting!!!!

 

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Several months ago, I posted an article that suggested that layoffs in the pharmaceutical industry were beginning to slow. Apparently executives at Bristol Myers Squibb (BMS) didn’t read my blog post (I believe that they have in the past) and today announced that the company will eliminate 840 jobs or 3 per cent of its 28,000 member workforce.

The company says the jobs will be eliminated over the next six months, and the cuts could be spread across all its businesses and geographic locations. A BMS spokesperson indicated that company executives are still reviewing the entire organization to determine which jobs will be eliminated. The new round of layoffs is intended to further streamline the company. Interestingly, BMS purchased Seattle-based Zymogenetics for $885 million two weeks ago.

These cuts coupled with small biotechnology company acquisitions and a recent stock buyback initiative suggests that the company may be positioning itself for sale or merger. BMS’ top selling drug Plavix which represents almost 40 percent of the company’s revenue stream will lose patent protection in 2011.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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The ever watchful Mark Senak of the highly informative EyeonFDA blog today reported that Eli Lilly had taken the social media plunge by creating a twitter account (@Lillypad) and also launching a blog cleverly entitled the LillyPad (get it; pad=launching point etc and the word pad is hot because of the iPAD). Ah, those clever pharmaceutical marketers; they never miss a thing!

As Mark points out in his post, Lilly had previously launched a YouTube Channel in 2008 called LillyDiabetes that almost immediately disappeared after he first blogged about it! According to the EyeonFDA post Lilly launched the blog and joined Twitter

"[b]ecause we feel passionately about a lot of issues that are important to our company and our industry, and we know there's plenty of passion well beyond our own walls.  Policy issues like health care reform have been top-of-mind with the public for a long time.  And industry watchers are placing an increased premium on trends like corporate citizenship.  These are important dialogues, and we're happy to provide a forum and participate."

However, as Mark aptly posited in his post, why are we so amazed when a pharmaceutical company launches a blog or engages in a social media campaign? After all, recent research indicates that nearly one-third of companies are blogging and that number is expected to increase to 43 percent by 2012. In fact, pharmaceutical company blogs are quickly becoming de rigueur. So, don’t be surprised if other companies jump on the social media bandwagon over the coming months. Maybe in the future the launch of a pharmaceutical blog, Facebook page or Twitterfeed may no longer be big news or even worthy of a blog post!

A quick perusal of the LillyPad blog reveals that many of the posts deal with issues like improving math and science education, job creation, American innovation, and healthcare solutions. Interestingly, many of these posts are consistent with recent public statements made by Lilly’s CEO John Lechleiter, PhD. It would be great if the LillyPad blog continues to post articles that provide Lilly stakeholders with insights into what management is thinking. This will certainly go a long way to help to create a “conversation’ between the blog and its followers: something that is critical to the success of any corporate social media campaign.

Until next time...

Good Luck and Good Job Hunting!!!

 

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Jena Ellis who works over at onlinecertificateprograms.org sent me a well written treatise on interviewing etiquette. While I have made similar recommendations in the past, the post entitled “Top 10 Interview Etiquette Tips” adds a few tips that I didn’t mention in earlier posts.

I highly recommend that folks preparing for a face-to-face job interview read this before their interviews! As most seasoned jobseekers will tell you, it is the little things during the interview like handshakes, eye contact, politeness etc that can make a difference between a job offer or not!

Top 10 Interview Etiquette Tips

Interviews are similar to first dates – intimate, intimidating and generally uncomfortable. Even some of the most confident, smooth-talking people get sweaty palms and tongue-tied during interviews. Nerves are one thing, but tardiness, bad manners and distracting behavior are completely avoidable. Just like it’s rude to put your elbows on the dinner table and swear in front of a lady, the same kind of etiquette should be followed during an interview. In order to make the best possible impression and let your qualities shine through, you’ll want to follow these top 10 interview etiquette tips to seal the deal: 

1.  Be early

Arriving 10-15 minutes before your interview demonstrates punctuality and responsibility. It also shows that you take the interview seriously and value the interviewer’s time. Being early is always better than being late, but be sure to give the interviewer enough time to prepare and don’t catch them off guard with your presence.

2.  Use a firm handshake

A handshake is commonplace before and after an interview. Shaking the hand of you interviewer is both polite and respectful, but it also shows confidence and openness to the interviewer. With that being said, a flimsy, weak handshake can send the wrong message and make you seem nervous or unprepared. If you’re worried about the grip, strength and overall feel of your handshake, practice beforehand with a friend or family member who can adjust your shake.

3.  Dress accordingly

Dressing for an interview can be tricky if you don’t know what the normal dress is for employees and really depends on the company, occupation and formality of the interview. To be on the safe side, it’s advised that you wear semi-formal business attire because it’s better to be a little overdressed than underdressed in an interview. As a rule of thumb, you shouldn’t wear jeans, flip flops or any other casual wear to an interview, unless noted. In addition, avoid distracting clothes, jewelry, hairstyles or makeup that will detract from you and your job qualities.

4.  Turn off your cell phone

If your cell phone goes off in the middle of an interview, you can pretty much kiss the job goodbye. Not only is this incredibly rude, but it may ruin what could have been a good interview. Even if you say you’re waiting on an emergency call and try to sugarcoat it, the interviewer may not approve and you could lose a potential job offer. When in doubt, always silence or turn off your cell phone – you can survive without it for 30 minutes.

5.  Make good eye contact

Eye contact is one of the most basic and telling nonverbal communication signals that take place in an interview. Making good eye contact with the interviewer shows your attentiveness and interest in the conversation taking place. Whereas, wandering eyes or poor eye contact make you seem disinterested or uncomfortable in what is being talked about.

6.  Tone down your nervous habits

You may pop your knuckles, twirl your hair and bite your nails when you’re nervous, but these fidgety gestures can be overly distracting in an interview. You don’t want the focus to be taken off of you and directed towards your bitten pen or shaking leg. To ease your nerves, take deep breaths and relax your body so you won’t feel anxious and revert back to your bad habits.

7.  Don’t chew gum

Bottom line – chewing gum during an interview is unprofessional and shouldn’t be done. If you’re chewing loudly, smacking your gum and blowing bubbles, that’s all the interviewer will be able to focus on because it’s incredibly distracting and bothersome in a serious scenario. If you need to freshen your breath, have a mint or use mouthwash before the interview.

8.  Say your please and thank yous

Good manners are always a plus in an interview. If the secretary or interviewer asks if you want a drink, always respond with a please and thank you. When the interview is over, be sure to thank the interviewer for his or her time and giving you the opportunity to interview. You can never say thank you enough.

9.  Think before you speak

Even if the interview is relaxed and takes a humorous turn, don’t slip up by telling jokes, talking about religion or politics or using profanity during an interview. You may be tempted to impress or say something memorable, but it’s best to act professionally the entire time and think before you speak. You don’t want an offensive joke to be the only thing they remember from your interview and risk losing a great job opportunity.

10.  Send a thank-you notes

Immediately following the interview, you should send a handwritten thank-you card or e-mail to show your gratitude. Not only is this a polite thing to do, but it also gives you an opportunity to remind the interviewer of who you, what position you’re interested in and what you talked about during the interview. This will help you stand out in their memory and possibly give you a leg up in the job standing.

Until next time..

Good Luck and Good Job Hunting!!!!!!

 

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Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.

Unlike other life sciences disciplines, a career in regulatory affairs is highly industry- specific and rarely taught at most academic institutions. In other words, if you are considering a career in regulatory affairs, don’t expect to get the training that you need in a PhD or postdoctoral training program; you will have to get it elsewhere!

A recent report compiled by the Regulatory Affairs Professionals Society (RAPS) entitled the “2010 Scope of Practice & Compensation Report for the Regulatory Profession” highlights the growing value and importance of regulatory affairs personnel in the life science industry. The report was compiled from the results of a survey of over 3000 regulatory affairs employees in 55 different countries.

The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).

Other important findings included in RAPS’ report include:

• US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified.
• The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC.
• Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008.
• Half of all senior-level respondents reported being involved in government affairs.
• About 70% of respondents said their work is either global in nature or focused on multiple regions of the world.
• More than 68% reported involvement with multiple product types, a 6.3% increase from 2008.
• Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars.
• Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased.
• Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.

If this sounds like a career option for you, I highly recommend that you visit the RAPS website. If you already have a PhD, masters’ degree or even a bachelor’s degree, getting RAC certification will certainly increase the likelihood of landing a regulatory affairs job in the life sciences industry. One caveat: the RAPS courses are not inexpensive and may require a substantial amount of time in order to pass the RAC examination.

If the RAC route doesn’t seem realistic or reasonable, try getting an entry-level job with the US Food and Drug Administration. Being an ex-agency employee will guarantee employment in the life sciences industry until you retire!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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Over 70 percent of hiring managers and HR professionals routinely use Google to find out more about prospective job candidates. While many jobseekers know this and do everything possible to expunge deleterious and compromising information from a Google search on their names, some don’t know that Facebook profiles are a routine target of all Google searches. Consequently, hiring managers may have access to some personal information (including photos) that may jeopardize a job candidate’s prospects.  

Today, German government officials proposed a new law that would place restrictions on employers who want to use Facebook profiles to recruit and vet job candidates. The bill would allow hiring managers to search for publicly accessible information about prospective employees on the Web and to view pages on job networking sites like LinkedIn, BioCrowd and Xing.  But it would not allow employers to access or use information about job candidates on purely social networks like Facebook. The proposed law would also prohibit companies from secretly videotaping employees except in certain areas as long as they disclosed the fact.

The idea of crafting legislation to limit company access to personal information of job candidates found on social networks like Facebook, Ning and others reveals the underlying paradox of the social media phenomenon. That is that people publicly, voluntarily and willingly offer private and intimate information about themselves as part of their right to freedom of expression and then that information can be used against them! In other words, the transparency and inherent freedom of expression offered by social media can in reality hinder, restrict or inhibit the professional and social opportunities of those who use it. I highly doubt that legislation similar to the proposed German law would ever see the light of day in the US.

For now, I highly recommend that jobseekers continue to routinely Google themselves to see what information is “out there” about them. Also, continue to limit access to personal profiles on Facebook and any other “purely social” online networking sites that you may belong too. Both activities will help to insure that the photo of you in a compromising position or with a beer bong in your hand won’t eliminate you as a prospective job candidate.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!

 

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Unlike PhD-trained scientists, physicians and other healthcare professionals must be licensed to practice medicine and are annually required to participate in continuing medical education courses (CME), seminars and lectures. CME training is required by medical licensing agencies to insure that healthcare practitioners are update to date with the latest clinical practices and informed about medical development within their respective fields. 

While all medical licensing agents require CME training, they do not fund or provide any of the content or learning materials required to implement that training. Historically, pharmaceutical, biotechnology and medical devices/diagnostic companies have underwritten the development for most CME courseware. Critics of this practice suggest that this represents clear conflict of interest concerns. And, in recent years, regulatory authorities like the US Food and Drug Administration, the American Medical Association and others have begun to agree with these suppositions. Consequently, the regulations that guide CME writing have drastically changed in recent years causing confusion among CME training providers and writers.

Despite growing concerns about the regulatory aspects of CME, there is still a high demand for persons who develop and write CME materials. While CME training is primarily geared towards physicians and other healthcare professionals, most of the content and training materials are prepared by PhD-trained scientists. Although a PhD in the life sciences is not an absolute requirement, many CME providers are beginning to hire persons with advanced degrees as developers and writers. Unfortunately, becoming a CME writing professional is not as easy as it sounds and requires some additional training beyond the PhD to break into the field. 

To that end, I recently became aware of a company called InQuill Medical Communications that offers training to life scientists interested in pursuing careers in CME writing. In addition to their courseware, InQuill offers a paid internship program to selected program graduate. The company is run by Johanna Lackner Marx who has over 15 years of experience in medical writing and developing and writing CME materials.

For more information about their training programs and some free information about careers in CME, please click here.

In the spirit of full disclosure, BioJobBlog is affiliated with InQuill. However, despite my over ten years of experience as a medical and science writer, I have had limited success in landing CME writing gigs because of my lack of formal writing and regulatory training in this area. That said those of you who may be interested in pursuing a career as a CME writer may benefit from the InQuill program!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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Mark Senak, a pharmaceutical social media advocate and the author of the EyeonFDA blog, today reported that the Swiss pharmaceutical giant Roche published on its website a document entitled Social Media Principles. The document outlines Roche’s rules and regulations guiding the company’s use and commitment to social media.

In an accompanying statement, Roche officially affirmed the role of social media as part of its Communication Policy.

Roche actively uses Social Media to communicate with its stakeholders. As committed in our Communication Policy we want to be a transparent company and thus welcome this new form of communication.

Further, while the company recognizes the use and benefits of social media, it acknowledged the regulatory risks associated with the new medium

Roche recognizes the ubiquity and benefits of social media and welcomes its use - however, we also acknowledge that certain risks are associated with these new channels. We have therefore developed this guideline to help our employees use these new platforms in a responsible way.

Finally and perhaps most importantly, Roche appointed Sabine Kostevc as Head of
Corporate Internet and Social Media. 

Contact

Sabine Kostevc

Head of Corporate Internet and Social Media

• http://twitter.com/skoko
• global.social_media @roche.com
• Media Team

She may be the first communication executive to hold an official title that has the phrase ‘social media” associated it. Surprisingly, this may be the biggest development of all; mainly because once one pharmaceutical company does something new, they all similar to follow!

Roche’s willingness to publicly commit to the use of social media is a bold and calculated move by a company that recognizes its power and the major role it will likely play in the future of the pharmaceutical industry. Further, it suggests that Roche, unlike most of its competitors, it willing to take a proactive role in helping to shape the social media regulatory guidelines being developed by the US Food and Drug Administration. Finally, Roche executives realize that increased transparency and open communications with its stakeholder may help to improve the public image of big pharma companies and perhaps rekindle the innovation that has been sorely lacking in the industry.

The bottom line: Rather than remaining part of the problem, Roche has boldly proclaimed that it wants to be part of the solution!

Hat tip to Mark and Roche!

Until next time...

Good Luck and Good Tweeting err Facebooking err Blogging!!!!!!!!!!!

 

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Despite assertions by its CEO that there isn’t enough scientific talent in the US, Eli Lilly announced that it will lay off a couple of thousand employees within the next 90 days. Most of the cuts will take place in Indianapolis at four different sites where the company currently employees about 13,000 workers. According to an article in today’s Indianapolis Star

“The struggling Indianapolis company, which has been cutting thousands of jobs in recent months, told the state on Monday that its downsizing is not temporary, but for the long haul.

The reductions in force at the Indianapolis sites of employment are expected to be permanent," wrote Kay Jackson, Lilly's senior director of human resources, in a letter to the Indiana Department of Workforce Development. She added that the cuts, when added up, are not expected to be more than 33 percent of the head count at any one site, or more than 500 workers at any site."

Like most of its rival big pharma companies, Lilly has cut the number of full-time equivalent workers by about 2,100 worldwide since last September. That's when it announced it would cut a total of 5,500 workers worldwide by 2011 to save $1 billion in annual costs. The reason for the cuts; an expected steep falloff in revenues over the next few years when the patents on Lilly's blockbuster drugs begin to expire and face low-priced generic competition  

John C. Lechleiter, Ph.D, Lilly’s CEO, contends that the lack of innovation and new product development at most American pharmaceutical companies can be explained by a dearth of qualified and adequately trained American scientists. Maybe this is why most pharma R&D job are currently being outsourced to China, India, Brazil and Eastern Europe? Alternatively, it may be cheaper to employ US-trained foreign nationals in these places rather than high priced American scientists who perform similar jobs in the US.  

Until next time...

Good Luck and Good Job Hunting (forget Indiana-not there is anything wrong with it)

 

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I read a post today on Yahoo News entitled “Warning on New Superbugs from S. Asia.” While I initially thought that this article may contain some important news on the real and growing of multiple drug resistant bacterial pathogens, I sadly learned that it was nothing more than an sensationalistic attempt to promote the discovery of a new metallo-beta-lactamase gene bla(NDM-1) in an Indian isolate of Klebsiella pneumoniae, a Gram negative bacterium. The work was performed by a group at Cardiff University in Wales and published almost a year ago in the journal Antimicrobial Agents and Chemotherapy.

There is no question that morbidity and mortality from Gram negative infections is rising and will certainly continue to increase in the future. This is because most of the work in antibacterial drug discovery in the last decade was focused on Gram positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE). Although new antibiotics have reached the market for these organisms, they are used judiciously, and mainly as a last resort, because of fears of emerging resistance to them among Gram positive clinical isolates. Unfortunately, developing new antibiotics against Gram negative pathogens as compared with Gram positive bacteria is much more difficult. To that end, no antibiotics of note have been discovered in recent years to treat multiple drug resistant strains of Gram negative bacteria. 

While identification of the bla (NDM-1) gene may be scientifically and biologically interesting, it will likely have little effect on the clinical treatment of Gram negative infections. This is because many Gram negative isolates are already resistant to most beta-lactam antibiotics and consequently these antibiotics are used only sparingly to treat many Gram negative infections. Regardless of the implications of the discovery of the NDM-1, what I find most troubling about the article is its title. It leads uninformed persons to believe that the world is in grave danger and that a pandemic of multiple drug resistant strains of Gram negative bacteria may be imminent.  While infections caused by multiple drug resistance strains of Gram negative bacteria are clearly on the rise, strains carrying the NDM-1 gene will not decimate the world population any time soon! In fact, the authors suggest that these strains may cause some problems in India which “already has high levels of antibiotic resistance.”

There is no doubt that informing people about the growing incidence of multiple drug resistant bacteria is a good thing. Maybe, if enough people get frightened they may be able to induce big pharmaceutical companies—many of which abandoned antibiotic drug discovery and development in the late 90s—to reinvigorate their programs. That said, it is not clear why this story got elevated to a lead story on Yahoo News since the discovery was made almost a year ago—maybe today is a slow news day? Nevertheless, the impending doom and sensationalistic tone of the article suggests that reporters who cover the life sciences need some training in microbiology. This is necessary to insure that the stories that they write about antibiotics are kept in the appropriate context and historical perspective. That said, don’t be surprised today if the sales of antibacterial products increase and the stock prices of biotechnology companies involved in antibacterial drug discovery and development spike!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

 

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While Pfizer has rapidly elevated its standing in life sciences social media circles, the announcement today that it is creating a “social media channel” on SlideShare suggests that the company may be over thinking its social media strategy. I have nothing against SlideShare (I even have some of my own presentations on the site) but SlideShare isn’t exactly a “household name” in social media circles. And, IMHO it isn’t exactly the most flexible or interactive social media platform available today. 

Ray Kerins Pfizer’s Vice President for External Affairs and Worldwide Communication proclaimed in as statement prepared for the channel’s launch: 

"This channel offers an integrated social media experience, delivering a variety of content -- presentations, video, blog posts -- via the largest online resource for sharing presentations.”We’re pleased to be the first company in a regulated industry to create a custom channel on SlideShare." 

Its launch was announced today at the 6th Annual PR & Communications ExL Pharma Summit being held this week at Pfizer’s New York world headquarters. After learning about the launch I visited the “channel” to have a peek.

Expecting a treasure drove of Pfizer blog posts, videos and other content I was sadly disappointed to find only a handful of PowerPoint presentations about Pfizer’s finances and quarterly results at the site (there were no blog posts, no videos, no followers and no tweets as promised). Also, it appears that the comments and wall section are currently disabled (I logged into my SlideShare account and was still unable to comment on the Pfizer site although @skypen managed to post a comment there). Although Pfizer may think it is leading the pharmaceutical social media vanguard, the launch of its SlideShare channel has already violated one of the basic tenets of social media— no over promising. And, for now, it appears that the Pfizer channel has been set up as a broadcast medium rather than an interactive one—another big no-no in social media circles. 

Maybe I expected too much of Pfizer (after hearing Ray talk at several social media conferences) and I am being too critical. But, launching a social media channel devoid of content and interactive feature is no longer de rigueur on the social web.  If this is what the world’s largest, and possibly one of the most social-media savvy, pharmaceutical companies has to offer, then we may be in for a long and bumpy social media ride in the life sciences industry!!!! 

Until next time... 

Good Luck and Good Viewing!!!!!!!

 

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Although the economy is in the toilet and unemployment remains high, highly skilled and ambitious employees are usually not at risk of losing their jobs. In fact, these employees are highly sought after and frequently contacted by recruiters trying to get them to “jump ship.” In other words, there will always be jobs for these employees even though the rest of us may be unemployed. Companies clearly recognize the value of these employees and will use all available strategies to retain them. 

During good economic times, this usually means a promotion and a concomitant salary increase. However, during recessionary times companies tend to promote these “good” employees into position with greater authority without a pay raise: the assumption being that tacking on a fancy new job title with some added responsibilities will be sufficient to stroke an employee’s ego and ignore the lack of additional compensation for a larger workload. 

To that end, the folks over at the online masters degree website recently posted an article entitled Job Title Stuffing 101: 12 Buzzwords to Inflate a Job’s Importance. It is a veritable tutorial on inflated job titles and the one that you ought to avoid (see below) if possible.

1. Manager: This title may be given to anyone and everyone who ever heads up a project or department, no matter how large or small. It’s used to give slight leverage to the person in charge of the task at hand, but can mean little to the project manager’s supervisors. Because many companies push team creativity, the manager is primarily responsible for turning things in and will be the one to hear about if the boss isn’t satisfied

2. Strategist: A strategist of any type simply means you plan tasks and have some idea of how these tasks are most efficiently executed. For example, in the case of a content strategist, it means you create and organize the content of a newsletter, website, or blog. Is the job important? Sure. But for some reason content strategist sounds a lot more impressive than web editor. You take your pick, but if the former is going on your resume, you better deliver.

3. Deputy: In the age of the Internet, there’s a deputy for many jobs. What does this mean? Well, it means you aren’t quite a junior or an assistant, but the company doesn’t have the funds to pay you like they would someone with the actual title. An example is an editor-in-chief versus a deputy editor. One issuse that you may run into being a deputy of any sort is more on your plate than you bargained for. But you’re the deputy, so you can handle it, right?

4. Senior: Companies love to tack this one onto a title. Senior web writer or senior designers are common for firms. What does this senior title translate to? Anyone with 5+ years of experience in a field and still utilizing those skills can serve as a senior, usually without the pay or responsibilities of management. Simply put – you do your job well, but the buck stops here.

5. Producer: This one has become popular for the web. Web producer pops up on many mainstream blogs and sites. A producer can wear many hats, and for a company that means more bang for their buck. Sure, you will be producing content, but expect handling anything the project throws your way even if it isn’t in the job description (and there’s a solid chance it won’t be)..

6. Supervisor: Like managers, this title can be hit or miss. For large corporations that have had to cut back and eliminate lower level management, pawning the title of supervisor off on an entry level employee who’s been in their cubicle for six months means having someone in the office to make sure things run well without having to douse them in a raise. There are some supervisors who are able to oversee a small department, but ultimately are not the first in command for their subordinates.

7. Ambassador: This job title buzzword is almost an insult to the actual word! In the age of promoting, you know, everything, the job title of brand ambassador is given to celebrities in a niche group that endorse the product sometimes without appearing in ads. This person is contracted by the company or simply receives perks and free services from the brand. They often do little more than show up at launch parties and events and plugs the company as needed. For Channel, The Misshapes Leigh Lazar serves as a brand ambassador and for AT&T, there’s Internet has-been Justine. The problem with brand ambassadors is often large corporations are the last to discover the new face of a niche audience.

8. Professional: A friend says that anytime you have to tack the word professional onto your job title, you must not have a real job. This is up for debate, but let’s take a look at a couple of titles that utilize the word. How about professional organizer? Or records distribution professional? By the way, the latter is the new uppity name for mail room clerk. Yes, even those fresh out of college need an inflated job title. Professional used to mean you had proper training for whatever you do, now it means you are paid some type of wage for what you do, no matter how little that is or the responsibility it entails.

9. Consultant: Who knows what you do with this title. It can mean you directly fix problems, as in the case of IT consultants or it can mean you merely offer your advice, in the case of interior design consultants. Many consultants bring in the big bucks and are contracted by major corporations, but many others work for themselves and struggle to get by. While this title isn’t necessarily inflated, it doesn’t really give the total picture of what you’re hired to do either (which you may prefer).

10. Vice President: Somewhere in the past decade, a lot more vice presidents have shown up to the company picnic. Instead of having a manager of ____, that job became VP of Public Relations or VP of Human Resources. It means second-in-command, in that department and not much more. There used to be only one

VP per company, but we’re guessing the more, the merrier, even if it is job title inflation in its boldest form.

11. Global: Even a mom-and-pop shop can have a Global Director of Communications. It can be mom, working from the family’s dry cleaning business to update the company’s Twitter and Facebook pages. Many companies are employing social media personnel and since a lot of these companies indeed do business around the world, why not stick the word global onto the job title of someone who represents your business to the world? It makes the job sound more exciting and may get you onto someone’s Follow Friday!

12. Lead: The word lead in a job title can mean a lot or a little. In some cases, it means you are heading up an operation, but in most cases it means the company is utilizing you for your skills and maximum potential without proper pay. Some companies use this title as a stepping stone between entry level and a lower management position to see if someone is ready for the next tier of responsibilities.

While promotion without compensation is not novel, it is rampant in today’s uncertain economic times. A word of advice: if you are being considered for a promotion, the first thing that I would ask is whether or not the promotion comes with a pay increase. If not, you ought to think twice about accepting the promotion and call the recruiters back who are trying to lure you away to a competitor’s company. Accepting a position with increased responsibility without a pay raise sends a signal to management that you can be exploited and taken advantage of. And, management will likely continue to exploit you until you call that recruiter back who tells you that a person with your title and level of responsibility can earn much more at a competitor company! That begs the question: Is job title inflation without compensation really a good way to promote employee retention? I think not!

Hat tip to onlinemastersdegree.org

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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An article in today’s New York Times business section loudly proclaimed that the number of people using Facebook had topped 500 million. Further, according to the article: “The company has grown at a meteoric pace, doubling in size from a year ago and each month, more than 30 billion photographs, links to Web sites and news articles are shared through the site, and its members spend roughly 700 billion minutes there.”  

While these statistics are mind boggling and represent an incredible business opportunity for any company, life sciences companies including most major pharmaceutical and biotechnology companies have largely shunned Facebook. In a post earlier this week on EyeonFDA, its author, Mark Senak rightly noted that:

 “When social media began to ebb from a media pathway for individuals to connect, to one where institutions and industry began to employ social media as a means of communicating with their constituencies Facebook has become an extremely important referral source - a driver of traffic - to Web pages.” Despite this, “the pharmaceutical industry, as a highly regulated industry, has lagged behind other sectors.”

The reasons for pharma’s reluctance to use social media to engage stakeholders are numerous. The most common ones offered include the lack of regulations guiding the use of social media and its possible effects on adverse event reporting for approved medicines. However, the lack of regulatory guidance and consequences for adverse event reporting didn’t prevent life sciences companies from building branded product websites, sponsoring patient communities or investing in social networks for physicians. Therefore, it is unlikely that the lack of regulatory guidance and fears of overwhelming adverse event reporting aren’t responsible for pharma’s reluctance to embrace social media. I suspect that the real reasons may have more to do with increasing transparency surrounding clinical testing, drug approvals and drug pricing and reimbursement. But, I digress....

Interestingly, despite the lack of regulatory guidance and concerns over adverse event reporting, some pharmaceutical companies have chosen to boldly go where no other life sciences companies have gone before on Facebook.  According to Mark, the following companies have created corporate or disease/cause-related fan pages on Facebook:

1. Labs Are Vital sponsored by Abbott Laboratories
2. AstraZeneca US Community Connections
3. AstraZenecaCareers
4. Bayer Karriere
5. Bayer Sustainability
6. Johnson & Johnson Network
7. Nursing Notes by Johnson & Johnson
8. Pfizer

While the number of person who are fans of these pages are minute (as compared with the total number of Facebook users) they likely represent highly committed and focused groups of user—any pharmaceutical marketer’s dream! Although Facebook still subscribes to the notion that “bigger is better, niche networking and social media sites are growing in popularity. This is because these sites may give marketers and advertisers a “bigger bang for their buck” as compared with larger, more unfocused and disparate user communities. In other words, penetration and uptake rates are likely to greater in focused niche populations as compared with the general population at large.

I have long contended that social media tools can be used for other than promotional purposes in the life sciences industry. To that end, the use of social media for clinical trial patient recruitment and retention is rapidly expanding and there are signs that pharmaceutical companies have finally recognized the power of social media for recruiting purposes e.g. AstraZenecaCareers .  

I have no doubt that the life science industry will eventually recognize the utility power of social media. It is no longer a question of “if” but rather ‘when” for social media and the life sciences industry?

Until next time...

Good Luck and Good Job Hunting!!!!!!!! 

 

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Let’s face it; there aren’t many employees in the workforce who have good things to say about their bosses. Bosses are generally reviled and in some cases the criticisms and pejoratives are truly warranted. To that end, while viewing my @BioCareers profile, I noticed that @eBossWatch was following me. The name piqued my interest ( I thought somebody was hawking Hugo Boss watches) and I clicked on @eBossWatch’s website to learn more.

Much to my surprise it turned out that eBossWatch has nothing to do with watches but everything to do with rating bosses! Founded in 2007, the website is designed to alert prospective employees about unsavory and difficult bosses before accepting a job offer. Bosses are rated by answering survey questions and each year eBossWatch assembles a list of America Worst Bosses. Also, you can search the site with your bosses name to see what his/her rating is. The site has been featured on Forbes.com, MSNBC, Business Week, the Los Angeles Times and the New York Post.

I think it is a great idea and one of my favorite parts of the website is its tagline: “nobody should have to work for a jerk.” Amen!

Until next time

Good Luck and Good Job Hunting !!!!!!!

 

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Some of you may have noticed that a new tab entitled “BioCareers” has been added to the BioJobBlog navigation bar.  If you click on the tab you will be taken to the BioCareers a new  job board and search engine agent created by Career Management Source and BioCrowd. 

BioCareers offers real time job listings, application tracking, and e-mail job alerts. Employers can post jobs, advertise jobs, search resume databases and have jobs listed on other jobs like Job Job-Job Health and Twitter jobs. 

The search engine that powers BioCareers automatically pulls life sciences jobs in real time and updates job searches when positions are filled or new ones become available. Candidates can search for jobs by location or job title. One of the nicer features of BioCareers is candidate e-mail alerts that are automatically generated when new jobs are posted or added in real time by the search engine.

To check out BioCareers click on the BioCareers tab or here.  We are in beta right now; so let me know what you think!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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There are signs that the economy is improving and that unemployment levels have dropped from a high of 10.1 % to current levels which are hovering around 9.5 %. While this is good news, job cuts continue at many pharmaceutical and biotechnology companies as drug candidates fail in clinical trials and technological advances make certain employees dispensable.

Yesterday, Johnson and Johnson announced that it would layoff 300 of 400 employees who work at the Fort Washington, PA plant that was responsible for the recent Tylenol brouhaha and recall. According to a post on the Pharmalot blog:

”The employees are being let go because it is not clear when the plant will operate again. A J&J spokeswoman says the “best estimate” is the middle of 2011. It isn’t clear at this point whether or not any McNeil executives who oversaw operations at the troubled facility will also be shown the door."

In other news, Adolor, a Pennsylvania-based specialty drug maker, announced yesterday that it was laying off 30 workers or 30 per cent of its workforce to preserve capital and advance its opioid bowel dysfunction clinical development program through proof-of-concept studies in 2011. Also on Friday, the company stated in a press release that two new drug candidates it was developing with Pfizer to treat pain caused by osteoarthritis did not work better than a placebo in a Phase II clinical trial involving 400 patients. The company has one drug on the market, Entereg, a treatment that helps restore bowel function in adults who have undergone bowel re-section surgery. Earlier in the week, GlaxoSmithKline, which co-developed Entereg, scaled back its relationship with Adolor.

Finally, Eli Lilly & Co told its employees that it plans to cut 340 information technology jobs in 2010. Most of the cuts will take place in Indiana (Lilly’s corporate headquarters is in Indianapolis). The company has 1,350 information technology employees nationally. Earlier this year, Lilly has said it will eliminate 5,500 jobs by the end of 2011 to save $1 billion.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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Whenever I do resume critiquing at scientific meetings, someone always asks about how to negotiate a job offer.  Most of the people that ask the question aren't even close to receiving a job offer and I do my best to deflect the question.  However, at a recent meeting, I spent 30 minutes with a PhD student who had received an offer advising him on how to get a better deal from his prospective new employer.  This got me thinking and I invited Joe Tringali, a veteran recruiter with lots of negotiating experience to write a blog post about strategies and things to consider when negotiating a job offer.

The "Dos" and "Don'ts" of Negotiating a Job Offer

by Joe Tringali

Invariably, the topic of salary negotiations in the interview process makes its way to the surface and, as a seasoned professional recruiter, I have a few thoughts that I would like to share with jobseekers.  During the course of my almost 30 year career, I have work as a traditional “headhunter” and also as on onsite contract recruiter for pharmaceutical and biotechnology companies, shifting gears and mindset as warranted by the particular client and the task at hand. In other words, I have been on both sides of the negotiating table either on behalf of a job candidate or a client company.

Fundamentally, job seekers need to understand the “economics” surrounding their search; who—the candidate or employer—has the most leverage in the relationship? Is there more demand than there is supply for a candidate with a specific set of skills or is there an excess of talent allowing an employer to choose the absolute best candidate for job. That said, consider the following:

A candidate who has received an offer can always try to negotiate to see how far they can push  the employer. As a rule of thumb, the initial offer that is proffered is usually not the best offer and if you aren’t satisfied with it, try and negotiate for a better deal.  If you ask and you don’t get what you want, the initial offer will likely still stand but you won’t have any regrets or say to yourself “I should have asked” if you eventually accept the offer. On the other hand, if the offer IS negotiable, it’s most likely only negotiable within a finite range. To that end, you must “come to the table” knowing your worth and what the compensation and benefits standards are for comparable positions in the industry. Rest assured that the prospective employer is at least as prepared as you are (usually more so) when it comes to negotiating offers. After all, most companies have dedicated compensation departments that spend a good portion of their workweek establishing fair compensation ranges. This doesn’t mean that you shouldn’t ask and attempt to negotiate, but simply that you must temper your expectations and not “expect the world.” Typically, employers are limited with what is negotiable in an offer. Things that are typically not negotiable are base salaries and healthcare and financial benefits. Other things like vacation time, sign on bonuses, relocation costs etc are. The reasons why base salary and benefits are not negotiable are because companies try to maintain internal equity among its employees.

When to negotiate? The obvious answer is to negotiate from a position of strength—when a formal offer has been extended (but never before). The offer signals that a company “wants you” and the candidate ought to consider the offer as it stands. Assuming the offer is fair (and the candidate SHOULD know his/her worth as part of the search process), accept it and move on with your career. Should you feel it isn’t quite up to par based on your understanding of your skills and marketplace demand, you might consider a conversation that sounds something like the following:

“I’m thrilled to receive the offer and am trying to find a way to make this work for both parties. My understanding of the market ( from online research, university career services, friends with similar experience, in similar roles, in similar geography,  is that an offer of 2k more might be more in line. IF there is any way you can bump the offer up by 2K, I will accept it and start on XXX date”

In other words, you are offering something back (acceptance/start date) in exchange for a possibly bump in the offer (most companies want you to start sooner rather than later). The worst case is that the employer comes back and says they cannot do any more with regard to compensation. Depending upon your assessment of the situation, you might then try to negotiate additional vacation days or an increase in relocation costs to offset the $2K that you need to feel comfortable to accept the offer. If the answer is still no, the original offer stands until you either accept or reject it—the decision is yours. Generally speaking, most offers are fair and in the range you might expect given your background and years of experience in the industry. But, only you can determine whether or not an offer is right for you. Ultimately, that decision ought to be based on compensation requirements, job responsibilities, geography, and whether or not an offer will meet your needs at this particular time in your life.

Until next time...

Good Luck and Good Job Hunting!!!!!

Joe Tringali is a Principal with Tringali & Associates, Inc., a recruitment consulting practice based in Manchester, New Hampshire. He has over 30 years of progressive experience in the field of Human Resources and is particularly well-qualified in the design and implementation of creative staffing programs and executive search practices within the Life Sciences. Some his clients include Pfizer, Eisai Pharmaceuticals, Millennium Pharmaceuticals, Biogen Idec, Genzyme , TKT/Shire , Harvard University and Infinity Pharmaceuticals.

 

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While the layoffs at pharma and biotech companies continue, the good news is that fewer jobs are being lost in 2010 as compared with 2009. Despite the massive loss of R&D and sales and marketing jobs, many life sciences companies are beginning to hire again. In general, job opportunities at emerging growth public biotech and venture-backed start-ups appear to be growing while those at big pharma and big biotech are stagnant or shrinking. Specifically companies are looking to hire:

1. Clinical affairs managers and executives
2. Regulatory affairs personnel and executives
3. Commercial and operational expertise at all levels
4. Business development executives
5. Chief financial officers
6. Investor relations and corporate communications professionals
7. CEOs (venture capital investors are beginning to part with their capital again)
8. Board of directors candidates (especially those with specific functional expertise in clinical development, regulatory affairs or commercialization)

A quick perusal of the list indicates that most of these jobs are not traditional science-related jobs and many may require additional training and expertise; especially in business. That said, now may be a good time to re-evaluate whether or not a MBA may be in your future.

Until next time....

Good Luck and Good Job Hunting!!!!!!

 

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John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an innovation crisis in the life sciences”

Lechleiter blamed the crisis on US tax and immigration policies over the last 10 years that have reduced research and investment funding and driven away foreign-born, U.S.-trained scientists.

He also attributed the problem to the US Food and Drug Administration’s new emphasis on drug safety.  “The FDA approved 92 drugs the last five years. That is the lowest of any five-year period,” he said. “We lose patent protections (on brand name drugs) and that is $100 billion less revenue for the industry and less for research and development” said Lechleiter. Further, he said that “American drug companies still spend 40 percent more on research in development in the U.S. than in other parts of the world.”

To avert the crisis, Lechleiter suggested the following: 

1. Increase and improve education for students in math and science
2. Change immigration laws to allow more H1-B visas for scientists and ease the process that allows immigrants to gain green cards to work in the U.S. The last time the H1-B visa cap was raised was in 1990
3. Increase federal funding for pharmaceutical and basic science research, which has declined over the last five years
4. Change tax policies to provide more incentives for research and development. The U.S. lags behind the rest of the world in offering R&D tax credits, he said. Moreover, the U.S. should not tax foreign subsidiaries of U.S. corporations

Lechleiter, who was trained as a chemist, is the only CEO of a major pharmaceutical company who holds a PhD degree. Therefore, his ideas resonate more for me than those of his business-only CEO counterparts. To that end, his suggestions regarding improving math and science education, immigration reform (which I have long contended is killing US competitiveness) and increasing federal funding for research make sense. However, the notion that US tax laws and lack of corporate tax incentives is stifling American innovation and competitiveness is pure hogwash.

While corporate tax rates may be higher in the US than elsewhere, there are so many loop holes that most corporations pay less than their share fair. Further, let’s not forget that the personal income tax rate is much higher in the rest of the developed world than it is in the US. It is just so “American” to not want to pay taxes and then demand and expect government services at no cost to the taxpayer (at least in Europe they pay high taxes and get good services).  And, let's not forget that despite their heavy tax burden it was American corporations not foreign ones that caused the recent global recession.

That said, I gotta give John some credit for his suggestions; three out of four (or a .750 average) isn’t bad in baseball or the pharmaceutical industry!

Hat tip to Ed at Pharmalot

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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Pharmaceutical giant GlaxoSmithKline (GSK) and MedTrust Online, an online oncology information site announced the development of CancerTrials App, the first free geo-locating oncology clinical trials application for the Apple iPhone and iPad platforms.

According to a press release, oncologists can easily find and share information about experimental therapies in clinical trials with their patients. CancerTrials App provides a quick search menu based on 12 common cancers and more advanced features that refine searches based on criteria such as gender, age, trial status and more. Once relevant clinical trials are found, results can be mapped relative to the location of the iPhone or iPad running the application. These features should help oncologists connect patients to appropriate regional and local clinical trials for which they may be eligible. Obviously, the app will help to bolster clinical trial enrollment in the oncology space.

While not a full blow geo-based social media platform like FourSquare,the Cancer Trials app is a step in the right direction and demonstrates the power of mobile medical applications and the potential of social media to improve clinical drug development. 

CancerTrials App for the iPhone and iPad is the first release of the application that connects to MedTrust Online's proprietary databases of oncology information. Other apps for RIM's BlackBerry and Google's Android operating systems will be released over the next several months.

Hat tip to GSK which has boldly gone where no other pharma company has gone before!

Until next time....

Good Luck and Good Job Hunting!!!!!

 

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For the past three years, I assiduously have attempted to track all of the major layoffs announced by big pharma and biotechnology companies. Quite honestly, it has been hard to stay on top of these almost weekly announcements. To date, over 200,000 life sciences employees have lost their jobs. And, I don’t think that job layoffs will abate for a year or more.

While pharma layoffs make sense in the short term—most notably to insure that stock share prices remain as inflated as possible—they are not going to solve pharma’s lack of innovation and the rising attrition rates for new molecular entities. On paper, outsourcing R&D make perfect fiscal and scientific sense. After all, there are literal thousands of US-trained scientists all over the world these days; mainly in China, India and Eastern Europe and it is much more cost effective to do research in these regions. However, in my opinion, outsourcing R&D, like layoffs, is a short term strategy that will likely backfire and not deliver the anticipated ROI. For example, many US technology companies that outsourced sizable portions of their operations in the early 2000 are now beginning to bring them back to the US as Asian labor costs continue to rise and product quality declines. This begs the question: what should big pharma companies do to regain their edge to bring new medicines to market?

Allan Haberman, of Haberman Associates, wrote a compelling post several months ago on his blog the Biopharmconsortium Blog where he offers some insights and strategies that may help big pharma out of its current lack of innovation and new product development.  Until that happens, I will continue to track pharma and biotech company layoffs as they are announced.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!

 

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There are rumors that companies are hiring again and that pharmaceutical jobs may begin to make a comeback over the next six months to a year. This  may be a real possibility based on a new report released yesterday the outplacement firm Challenger, Gray and Christmas, Inc.

According to the report , 51,034 pharmaceutical employees lost their jobs by the end of May 2009. In contrast, by the end of May this year, only 34,157 pharma employees received pink slips. This represents a 33% reduction in the number of people being layed off as compared with the same time period last year. 

These data can be interpreted in a couple of different ways. First, fewer pharmaceutical employees are getting layed off which means that the economy may be getting better and the job market may be improving. Second, pharma companies can no longer continue to layoff employees at 2009 rates without impacting their with day-to-day operations.

Personally, as a half-empty kind of guy, I think the later hypothesis is more likely! Only time will tell whether or not the economy has truly turned a corner and when we can expect pharma companies to begin hiring en masse again.

Hat tip to Ed at Pharmalot.

Until next time...

Good Luck and Good Job Hunting???

 

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Last week I attended the Advanced Learning Institute’s conference on social media and pharma. During several question and answer periods, I raised the idea about using social medial tools to improve adverse effects (AE) reporting and post marketing drug surveillance activities. While there was a lot of head nodding suggesting that many of the conference attendees agreed with the points I was making, the conversation about social media and AE reporting was extremely muted. I suspect that most pharmaceutical and biotechnology companies don’t want to discuss the topic until the US Food and Drug Administration issues its mythical regulatory guidance on the use of social media for promotional and other purposes some time next year (?).

John Mack aka Pharmaguy is an ardent supporter (like me) of the use of social media for AE reporting. John was at the meeting and he mentioned that the next day he would be giving a talk on that topic to the World Drug Safety Congress in Washington, DC. Conveniently, he posted a copy of the talk to Slideshare and his blog, Pharma Marketing Blog before his talk.

John’s ideas and insights into the use of social media tools for AE reporting are spot on (and consistent with mine of course!). I highly recommend that those of you who are interested in learning more about this topic take a look at the presentation; it is very informative and quite well done.

It is anybody’s guess at this point whether or not pharma will embrace social media and use it for more than promotional and marketing purposes. However, there is a growing body of evidence which suggests that pharma is beginning to realize that they can no longer fight the pressure from its stakeholders to embrace social media.

Stay tuned for late-breaking social media and pharma news!

Until next time...

Good Luck and Good Tweeting, Blogging, Videoing etc!

 

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Melville, NY-based OSI Pharmaceuticals, the maker of the cancer drug Tarceva and arguably one of the most successful biotechnology companies in the New York metropolitan area, has finally agreed to be purchased by Japan’s Astellas Pharma.

Earlier this year, Astellas announced a hostile takeover bid for OSI. After a two month long battle, the OSI board agreed to sell the company to Astellas for $4.0 billion. According to the terms of the deal, OSI shareholders will receive $57.50 per share; a 55 per cent premium to the company’s share price in February. The price represents a 10.5 percent increase over Astellas’ original proposal of $52 per share.

Tarceva is OSI’s only product but sales last year reached about $1.2 billion. The drug has been approved to treat various cancers including non-small cell lung cancer (second line treatment) and first-line advanced pancreatic cancer. OSI has been trying to garner approval for Tarceva to treat other types of cancer in recent years. While sales of Tarceva have been growing annually, OSI’s new drug pipeline has been relatively thin.

OSI was founded in 1983 and is one of the oldest biotechnology companies in New York State. The company currently employs about 524 people. It is not clear what effect, if any, the acquisition may have on those jobs.

Astellas Pharma is Japan’s largest pharmaceutical company which has been on something of a buying spree to enhance its oncology portfolio and expand its US presence. Last year, Astellas lost a battle to acquire CV Therapeutics which was ultimately purchased by California-based Gilead Sciences for $1.4 billion.

Over the past few years Japanese pharmaceutical companies, flush with cash, have been aggressively pursuing American biotechnology companies with oncology expertise. Two years ago, Takeda Pharmaceuticals purchased Boston-based Millennium Pharmaceuticals for $8.8 billion to gain access to Velcade, its multiple myeloma drug and oncology drug pipeline.

The recent Japanese biotechnology buying spree is reminiscent of the Japanese real estate grab in the late 1980s which resulted in the sale of some of America’s iconic buildings including Rockefeller Center and the Empire State Building. Ironically, those buildings are again owned by American companies and private equity groups! 

Until next time…

Good Luck and Good Job Hunting!!!

 

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Over the course of a 30 year career and countless interviews, at one time or another I have been invariably asked: “What are your greatest weaknesses?”

The first time I was asked this question (1994) I almost said to the interviewer “Say what!!???!!!” Needless to say, the question took me totally by surprise and although I fumbled my way through the answer, I knew that I had blown it. A job offer never materialized.

The reason the question “through me for a loop” is because nobody had ever asked me that question while I worked in academia. After all, academics are taught to never reveal their weaknesses because that would be tantamount to admitting that they may be fallible which, in turn, may give others a reason to question their data…but I digress!

So, here is the bad news. For those of you seeking industrial and non-academic jobs, I guarantee that you will be asked the weakness question. Typically, it is delivered by Human Resources (HR) representatives who are asked to meet with job candidates during the interview process to go over things like salary, vacation time, benefits etc. However, based on my own experiences over the past few years, more and more non-HR folks seem to be asking the question.

Now, here is the good news; the question is not that difficult to answer if you think about it in advance and prepare a well thought out answer. The goal of the exercise is to identify (or create) a weakness that, if correctly crafted and presented the right way, can actually be perceived as a strength or positive personal trait.

During my “Interviewing Insights and Tips” seminar I usually give participants a few examples of strong weaknesses. Unfortunately, I’ve been using the same examples for the past five years or more and I think many HR professionals may be onto to my “answers. “ Consequently, I think it may be time for all of you smart and creative folks out there to come up with your own weakness.  To help with this, I recommend that you watch the following video.

Addendum: Never, ever tell an interviewer about a REAL or RECOGNIZED weakness, e.g., I don’t like interacting with people or I don’t like being told what to do. This will eliminate any possibility of a job offer. I know that the whole weakness thing may sound silly to many of you, but I can assure you that in the real world it may mean the difference between employment and living with your parents!

Until next time…

Good Luck and Good Job Hunting!!!!!!! 

 

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There is a growing controversy over the rules governing whether internships offered by employers should be paid or unpaid. Many wage and hour regulators maintain that interns must be paid when their work is of “immediate advantage” to the employer. In this case, the interns should be considered employees and must be paid at least minimum wage. However, as the number of internships continues to rise, an increasing number of interns have complained of being placed in unpaid positions doing largely unskilled or menial work. Most labor experts agree that this provides an immediate financial advantage to an employer because the intern is doing unpaid work that is typically performed by a paid employee. 

Because of the growing popularity of internships, the federal government has established six criteria to determine whether or not internships can be unpaid. These include that the internship must resemble instruction or training given in a vocational skill or academic institution and that the intern does not displace or replace a paid employee and that the employer does not gain an immediate advantage from the intern’s work and activities. In other words, if an intern’s experience is mainly educational or beneficial to the intern the internship does not have to be a paid one. To confound the issue, the California labor department recently issued new guidelines on whether or not internships should be paid, with the new rules giving employers more latitude not to pay them

According to a recent article in the New York Times, the new rules stipulate that interns need not always be paid when they do some of the same work as company employees. The new guidelines suggest that interns could do occasional work done by regular employees as long as it “does not unreasonably replace or impede the education objective for the intern and effectively displace regular workers.” I suspect that other states will follow suit and redefine their criteria for unpaid internships.

Don’t be surprised if you see a spike in the number of unpaid internships offered for the summer of 2010 and beyond.

Until next time…

Good Luck and Good Job Hunting!!!

 

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There was a troubling article in this past Saturday’s New York Times that revealed that an increasing number of employers are using job applicants’ credit scores to determine whether or not to hire them. Persons with poor or lower credit scores are assumed to be less reliable and trustworthy employees (despite experience and skill sets) as compared with those with good credit scores. Interestingly, while many would be employers subscribe to this notion, there are no data whatsoever to support the claim! In other words, there is no scientific or statistical evidence showing that people with weak credit are more likely than those with good credit to be bad employees or steal from their employers. Because of the recession, many people’s credit scores have been adversely affected. This has prompted legislators in 13 states to introduce bills to limit the use of credits reports as a factor in the hiring process. To date, three states have passed such laws.

Supporters of these laws contend that the use of credit checks to screen prospective employers unfairly targets a huge pool of individuals whose credit was damaged by layoffs, medical bills or other factors beyond their control. This caused one Connecticut legislator, who recently introduced legislation to curb the use of credit checks by employers to quip “Bernie Madoff had a pretty good credit score. And yet there is this consistent message that if you have a bad credit score, there is something wrong with you.” Finally, and perhaps most egregiously, the practice tends to disproportionately screen out prospective minority employees. 

Not surprisingly, companies that sell credit checks (Experian, TransUnion, etc) have mounted a vigorous lobbying campaign against any legislation limiting the use of credit check by employers in the hiring process. These lobbyists contend that preventing the use of credit checks could seriously jeopardize a company’s assets, reputation or security.

A survey released earlier this year by the Society for Human Resources Management revealed that 13 percent of employers used credit checks on all job applicants whereas 47 percent say they use credit checks for certain applicants. Among those surveyed, 54 percent said they use credit checks on prospective employees to prevent theft and embezzlement. Ninety0one percent they used credit checks for job applicants seeking positions with fiduciary or financial responsibility. Most of the proposed bills to curb the use of credit checks allow them to be used for positions that involve the handling of money or confidential and proprietary information.

Unfortunately, in the current economy, employers are looking for any excuse to not hire certain job applicants. In my opinion, the growing use credit scores to screen job applicants is offensive and demeaning and should not be a determining factor (unless handling money is involved) in the hiring process. It is an overtly discriminatory practice that can seriously impede hardworking people from securing gainful employment to provide for themselves and their families. Kudos to the legislators who possess the moral and ethical convictions to propose legislation that protects the rights of jobseekers who simply want to make a living.

In case you are wondering, my credit score is in the mid 750s. Conventional wisdom suggests that scores below 600 may be dicey. With this in mind, I highly recommend that you check your credit score before you go on your next job interview—it may give you some insight into whether or not to expect a job offer.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

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According to a post on Pharmalot, a great blog run by the intrepid Ed Silverman, Sanofi-Aventis is laying off 400 employees; most of the them sales representative. The layoffs are in response to impending generic competition for several of the company’s older medications— the Ambien CR sleeping pill and Aplenzin antidepressant and declining sales of Actonel an osteoporosis medication. And, based on statements made by a company executive who manages the company’s therapeutic portfolio this may only be the tip of the iceberg as revenues from brand drugs continue to decline over the next few years.

Until next time..

Good Luck and Good Job Hunting!!!!!

 

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The recent economic downturn, coupled with the growing competition for jobs at pharmaceutical and biotechnology companies, has markedly increased the importance of internships as pre-requisites to gainful permanent employment. In the past, life sciences companies were willing to take a risk on promising new employees who did not possess any previous work experience. However, the glut of life scientists on today’s job market has empowered prospective life science employers to adopt a “let’s-try-them-out-before-we-hire-them” approach to employment. Like it or not, this is the way business is done these days.

While many life sciences companies continue to compensate their interns, an article in this past Saturday’s New York Times suggested that there is a growing number of organizations that are failing to pay their interns. This has caused federal and state regulators to worry that more employers are illegally using such internships for free labor. Many regulators say that violations are widespread, but that it is unusually hard to mount a major enforcement effort because interns are often afraid to file complaints. Many fear they will become known as troublemakers in their chosen field, endangering their chances with a potential future employer.

According to the article, in 2008, the National Association of Colleges and Employers found that 83 percent of graduating students had held internships, up from 9 percent in 1992. This means hundreds of thousands of students hold internships each year; some experts estimate that one-fourth to one-half are unpaid. Further, there are data to suggest that unpaid internships have been skyrocketing in recent years; mainly fueled by employers’ desire to hold down costs and students’ eagerness to gain experience for their résumés. For example, a career development expert at Stanford University noted that “employers posted 643 unpaid internships on Stanford’s job board this academic year, more than triple the 174 posted two years ago.” Other universities report similar trends.

While the primary goal of internships is to educate and prepare students for future jobs in their chosen fields of endeavor, some employers tend to view even paid interns as free labor and: asking them to do perform unskilled, menial tasks rather than pay hourly workers to perform them. Nevertheless, there is no question that spending a summer or semester as an intern at a life sciences company seriously increases the likelihood of permanent employment (either at that company or one of its competitors). After all, the internship experience (whether or not you performed any relevant work) qualifies as previous industrial experience. And, as many recent jobseekers will tell you, “previous industrial experience” is an absolute requirement these days to land a permanent job at a life sciences company. 

In the past, I unabashedly recommended that students who want to land jobs at life sciences companies consider taking an unpaid internship if a paid one wasn’t possible. However, I am no longer certain that this approach may continue to be viable or valuable one. To that end, working as an unpaid, life sciences intern taking lunch orders, fetching coffee, copying journal articles or conducting PubMed sources for the VP of R&D may not be helpful to you or a prospective new employer.  With this in mind, I suggest that before agreeing to a life science internship (paid or otherwise) that you ask for a job description and a list of your responsibilities and functions. If a company is unwilling or unable to provide you with this information, I highly recommend that you move on to the next possibility. After all, nothing is life is free!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

 

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Pfizer today announced that it would lay off another 123 workers at its Pearl River, NY manufacturing and R&D site.

The workers in the facility's research and development division will lose their jobs by early July according to a company spokesperson. He added "There may be some additional positions eliminated over the course of 2010, but this is the last major wave that will be announced.”

This brings to 601 the total number of layoffs at the site. The cuts are part of a global restructuring Pfizer announced in November, weeks after acquiring Wyeth Pharmaceuticals. The company has yet to decide the fate of the plant's manufacturing arm. If it is shuttered, that could lead to more layoffs

In other news, lesser known KV Pharma said it would shed 289 workers or 42 percent of its workforce. KV already had reduced its staff from 1,700 in 2008 to about 680 as of Feb. 28. The company recently shut down its generics subsidiary Ethex Corp. after the company pleaded guilty to criminal charges for not disclosing problems with two of its drugs and agreed to pay $27.6 million in fines and restitution.

While the US government and financial analysts claim that the economy is show signs of improvement, the layoffs at pharma and biotech companies continue. Only time will tell if we have truly turned a corner during this economic downturn.

Hat tip to the Pharmalot blog!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Roche disclosed in a regulatory filing that it will plans to eliminate 500 positions in New Jersey by the end of this month, related to last year's acquisition of Genentech Inc., and plans to cut another 100 jobs in the state by June. While the cuts were expected after Roche acquired Genentech last year and announced it would move its US headquarters from Nutley, NJ to South San Francisco, it wasn’t clear how extensive the job loses would be. The company is closing down all manufacturing operations at the aging Nutley site.

This is more bad news for the State of New Jersey which has borne the brunt of the pharma downsizing trend that began in earnest about 4 years ago. As many of you may know, New Jersey has the highest concentration of pharmaceutical employees in the US. The loss of pharmaceutical jobs coupled with an enormous budget deficit suggests that it will be many years before New Jersey is able to recover from the economic downturn.

Roche, which had 2009 revenue of about $45.9 billion, employs more than 80,000 people worldwide.

Until next time…

Good Luck and Good Job Hunting (forget New Jersey)

 

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AstraZeneca today announced that its Chief Executive David Brennan will receive no increase to his base salary this year, as the drug maker continues a freeze for top executives imposed last year due to weak economic conditions.

Brennan's 2010 salary will remain at $1.4 million, the same level since 2008. However, Brennan’s overall compensation has been on the rise for the past few years. His total remuneration, which includes bonus, shares and other items, rose 5% to $4.9 million for 2009, versus $4.7 million for 2008, according to documents recently filed with the Securities and Exchange Commission.

AstraZeneca said the base-salary freeze for 2010 also applies to other senior executives whose responsibilities are unchanged. 

While it is laudable that the company is freezing the base salary of its executives, most of their annual compensation is derived from bonuses, stock grants and options and other perks and benefits. I am certain that the hundreds of thousands of pharmaceutical employees who lost their jobs over the past three years can sleep better at night knowing that pharmaceutical executives are finally feeling the pain and sharing the pain of a down economy.

Hat tip to Ed at Pharmalot!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!

 

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While I was pleased that President Obama and the Democrats were finally able to deliver much needed reform to an ailing American healthcare system, the compromises that were made to pass the bill are troubling. First, language allowing reimportation of lower cost drugs from Canada and other developed nations was eliminated from the bill. Second, the provisions allowing the contentious 12 year data exclusivity provision for generic versions of biologic and biotechnology drugs remained in the final bill. Finally, and perhaps most importantly, any language alluding to or implying that the US government, may, in the future, be able to negotiate or regulate drug prices was obliterated. In short, the pharmaceutical and biotechnology industries received all of the assurances and guarantees that were in the deal brokered by Billy Tauzin, the former head of the lobbying group PhRMA, between the White House and PhRMA over a year ago. Surprisingly, Tauzin was fired by PhRMA several weeks ago because its leadership mistakenly thought that Tauzin conceded “too much” to the Obama Administration when he brokered the original health reform package with the White House. (At the time that Tauzin was fired, health care reform legislation appeared to be on life support and all but dead).

In the final analysis, big pharma and biotech will give back $85 billion over ten years —largely by agreeing to give back some of the profits it was allowed to collected from the egregiously flawed Medicare Part D legislation passed during the odious Bush Administration. While $85 billion may seem like a lot (to the average American citizen) to give back, it is important to note, that the size of the global pharmaceutical and biotechnology markets is over $600 billion per year. Although growth in these markets is beginning to slow in developed nations like the US and Japan (to high single digits), it is beginning to explode in heavily populated developing nations like China, India and Brazil where it is roughly $12-18%. Put simply, despite assertions to the contrary, business in the biotechnology and pharmaceutical markets is booming and likely to continue for the foreseeable future. In other words, the newly passed healthcare reform legislation is a “sweetheart deal” for the US life sciences industry.

Ironically, while the healthcare reform bill insures that almost all Americans will be entitled to healthcare coverage and that insurance companies cannot deny healthcare benefits to persons with pre-existing medical conditions, the legislation may actually limit the access of Americans to potentially life-saving biotechnology drugs. This is because the 12 year data exclusivity period for generic versions of branded, biotechnology drugs (otherwise know as follow-on biologics or biosimilars) remained in the final version of the healthcare reform bill.

As I previously mentioned, this provision disallows approval of follow-on biologics for a period of 12 years from the data that the original biologic received US regulatory approval. For example, if a branded biologic or biotechnology product garners US regulatory approval in 2010, the earliest date that a generic version of this product would be able to appear on the US market would be 2022. Moreover, in some instances, the 12 year data exclusivity provision may extend the so-called patent life of a product. Using the example above, if the patents protecting the product happen to expire in 2019, the innovator company is guaranteed an additional three years of marketing exclusivity before generic versions of the product can appear on the US market. Finally, the 12 year data exclusivity provision effectively prevents foreign biosimilar manufacturers from competing in the US biotechnology market until about 2018; a strategy designed to allow the US to maintain its dominance of the global biotechnology market. Interestingly, despite the approval of six or more biosimilars in Europe, these products have failed to catch on and are not able to compete with their branded, innovator counterparts.

In conclusion, I laud President Obama’s persistence and give him props for his ability to deliver (as promised) health reform to the American public. I have no doubt that the legislation will help to improve the delivery of healthcare in the US and hopefully improve the overall health of Americans. However, while the new healthcare reform legislation is a first, positive step, the American healthcare system will never entirely be “fixed’ until US drug prices are regulated—like they are in the rest of the world. Then, and only then, will the US government be able to control and contain healthcare costs in America.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

 

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Abbott Laboratories yesterday announced that it will buy Facet Biotech Corp. for about $450 million in cash. Facet, along with its development partner Biogen Idec, had planned on moving a potential monoclonal antibody (MAb) treatment for multiple sclerosis called daclizumab into late stage clinical development in the second quarter of this year. The company is also developing several different cancer treatments with other pharmaceutical partners.

Abbott’s purchase of Facet signals Abbott Laboratories’ ongoing commitment to biotechnology or protein-based drugs. The company launched Humira (a fully human MAb treatment for rheumatoid arthritis and other inflammatory diseases) several years ago and it has managed to glean market share from older competitor’s products including Remicade (Johnson & Johnson) and Enbrel (Amgen/Pfizer) to become a blockbuster drug. MAbs are viewed by many as the “drugs of the future.” At present, there are over 350 MAb-based products in various stages of discovery and clinical development.

Earlier in the year, Biogen Idec offered to purchase Facet for $17.50 per share. Company executives and shareholders rejected the offer citing that they thought it was too low. Abbott offered $27 per share which represented a 67 percent premium to Facet’s closing stock price of $16.21 on Tuesday.  Both companies’ boards of directors have already approved the deal which is expected to close some time in the second quarter. It is not clear how the purchase will affect Facet employees but expect to see layoffs and a mass exodus by company executives.

Look for more cash purchases of biotech firms by pharmaceutical companies as debt continues to accrue and venture money remains scarce and difficult to come by.

Until next time...

Good Luck and Good Job Hunting!!!

 

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For the past year or so, I have been focusing on the downsizing and layoffs taking place at big pharmaceutical companies. The unprecedented size and scope of these massive layoffs have overshadowed the downsizing and job loss taking place at small to mid-size public and private biopharmaceutical companies. In contrast with most fully-integrated vertical pharmaceutical companies that are flush with cash, most biotech companies—even the likes of Amgen, Genentech, Gilead and others—don’t have the cash reserves to maintain operations in a down economy or when a drug candidate fails in clinical development. This coupled with the lack of venture and private equity capital has been causing biopharmaceutical employees to lose sleep in recent months.

Over the past few days, two CA-based biopharmaceutical companies announced major layoffs. The first, San Jose-based Xenoport, announced that it plans on cutting its 222 person workforce by 50% over the next few months. According to company executives, the layoffs are necessary because the US Food and Drug Administration (FDA) failed to grant approval to its lead drug candidate Horizant, a treatment for restless leg syndrome. This will allow the company to annually save about $15.6 million and focus its development efforts on other products that are in Phase II clinical development. 

San Francisco-based Exelixis today announced that it would cut about 40% of its workforce or 270 employees to focus on development of its late stage drug candidates. The biotechnology company, which expects to reduce its 2011 cash expenditures by about $90 million, said it would focus on the development of its anti-cancer drugs XL184, XL147 and XL765. These layoffs are occurring less than a year after the company announced a potential $1.0 billion deal with Sanofi-Aventis in which Sanofi invested $140 million upfront to license two of its oncology drug candidates.

Things are also not going well for the numerous small to midsize biotechnology companies in the Seattle area. According to Xconomy, a company that tracks layoffs in and around Seattle, the region has shed 4,500 biopharmaceutical industry jobs since 2008.

Finally, BNET compiled a top biotech layoff list for 2009. The notables that made the list are shown below.

1. Sepracor (530). The layoffs represented 20 percent of Sepracor’s workforce, and another 410 contract sales reps also got the axe. The restructuring apparently worked and Dainippon Sumitomo Pharma the company later in 2009.
2. Allergan (460). This represented a five percent reduction in the company’s workforce.
3. Genmab (300).  Arzerra (ofatumumab) the company’s leukemia drug won FDA approval a week before layoffs were announced (go figure). But Genmab wanted to cut manufacturing and late-stage clinical work to refocus on antibody discovery.
4. Oscient Pharmaceuticals (280). Oscient cut about 100 jobs in February, 2009 to entice acquisition partners. When that didn’t work, the firm cut another 180 in June as it dumped the sales force for its two marketed products. Cornerstone Therapeutics later picked up Oscient’s antibiotic Factive during bankruptcy.
5. Amylin Pharmaceuticals (200). After cutting 340 jobs at the end of 2008 amid declining diabetes drug sales and regulatory delays, Amylin eliminated 200 sales reps in mid-2009.

While these represent the largest layoffs that occurred in 2009, thousands of other biopharmaceutical employees also lost their jobs.  If the life sciences sector is the part of the economy that has been relatively unscathed during the economic downturn, imagine what life must be like for employees in other sectors that have been hard hit!

Until next time...

Good Luck and Good Job Hunting ????

 

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In case you did not know, the 12 years of market exclusivity proposed for follow-on biologics by supporters and lobbyists for the pharmaceutical and biotechnology industries is part of the impending US healthcare reform legislation currently pending in Congress. While President Obama has publicly announced that he supports a five year period of data exclusivity for biologics (the same as the exclusivity period for generic small molecule drugs, it is unlikely that the President will be able to convince or coerce legislators to reconsider the 12 year data exclusivity provision. However, there was a brilliant Op-Ed piece in today’s New York Times written by Anthony So and Samuel Katz at Duke University which offers a plethora of financial and business reasons why the five year period makes a lot of sense!

1. Generic small molecule drugs have been estimated to save the American healthcare system as much as $734 billion over the past 25 year or so since the inception of the Hatch Waxman Act.
2. Biologics cost on average 22 times more than equivalent brand name prescription small molecule drugs
3. In 2008, 28% of sales of the life science industry’s top 100 products came from biologics and biotechnology products: by 2014 that share is expect to rise to about 50%
4. The Medicare Payment Advisory Commission found that the top six selling biologics which include Epogen (Amgen) Avastin (Genentech) and Remicade (Centocor) accounted for $7.0 billion (43%) of Part B drug spending in 2007 (Part B covers the cost of doctor spending and outpatient visits)
5. Between 2006 and 2007, Medicare Part D (prescription drug coverage) spending on biologics increased by 36% as compared with a 22% increase in spending for small molecule drugs
6. Prices for biologics and biotechnology products have increased more rapidly than those for small molecule drugs
7. While industry leaders and their lobbyist contend that it costs more and takes longer to develop biologics and biotechnology products than small molecule drugs, based on reports by various industry trade groups it costs about $1.2 billion to develop biologics and roughly $1.318 billion for small molecule drugs
8. The US Federal Trade Commission, the independent federal agency whose main goals are to protect consumers and to ensure a strong competitive market by enforcing a variety of consumer protection and antitrust laws, recommended that the data exclusivity period for follow-on biologics should not exceed six years.

Despite the likelihood that follow-on biologics will substantially reduce prescription drug costs and healthcare spending, Congress has chosen to support questionable legislation that will delay access of Americans to less costly, efficacious follow-on biologics until at least 2020.

Until next time...

Good Luck and Good Job Hunting

 

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Mark Senak, author of the incisive EyeonFDA blog and de facto watchdog of all things social media in the life sciences, has assiduously been tracking company and trade organization input to the docket for the Part 15 meeting on medical product promotion and the internet and social media. To date, according to Mark, the following companies and trade groups have officially submitted their comments and viewpoints to the docket                                                                                              

1. Covidien
2. Johnson & Johnson
3. Bayer Healthcare
4. Sanofi Aventis
5. AstraZeneca
6. Eli Lilly
7. Medtronic
8. Pfizer
9. Abbott
10. Novartis
11. Genentech
12. Sepracor
13. Merck
14. Medtronic
15. Biotechnology Industry Organization (BIO)
16. PhRMA
17. National Organization for Rare Disorders (NORD)

As you may recall, industry input was lacking and surprisingly absent from the public hearings held by FDA on the topic earlier this year. While news analysts and bloggers were incredulous that companies didn’t actively participate in the earlier public hearings, this behavior is typical of life sciences companies that like to do things quietly and, when possible, behind closed doors. Ironically, this lack of transparency and inclination to secrecy is the antithesis of social media. Is it any wonder then, that life sciences companies are suspicious and wary of the impact that social media may have on their ability to conduct business?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Ed Silverman, who runs the Pharmalot blog,reported today that AstraZeneca provided more details about its plan to layoff 8,000 employees or 12% of its workforce by 2014. 

According to the post, the company will R&D programs in thrombosis; acid reflux; ovarian and bladder cancers; systemic scleroderma; schizophrenia, bipolar disorder, depression and anxiety; hepatitis C and vaccines (other than respiratory syncytial virus and influenza).

The company will shutter research facilities throughout the UK and Sweden and shed about 3,500 R&D jobs. About 550 jobs will be eliminated at AstraZeneca’s US headquarters in Wilmington, Delaware; adding to the massive numbers of unemployed pharmaceutical workers in the Pennsylvania, New Jersey and Delaware region. The company is also looking for a buyer for its Arrow Therapeutics business.

AstraZeneca joins a growing number of big pharma companies that are jettisoning internal R& D programs in favor of licensing and merger and acquisition deals to sure up drug discovery pipelines. The lack of innovation in small molecule drug discovery and the loss in 2011 of patent protection for some of the industry’s largest blockbuster drug franchises is forcing big pharma companies to eliminate or outsource most of their R&D functions and capabilities to cut costs.  

I wish I could say that things will get better. But, the shift in the business model that has guided big pharma for close to 100 years is likely to be a permanent one. Now is the time to begin to consider alternative career paths!

Until next time...

Good Luck and Good Job Hunting (“Go West young man/man!”)

 

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For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has forced many small to mid-sized companies to rely again on American CMOs to manufacture their products. Unlike cash-rich, larger companies, US small to midsize companies generally lack the financial resources and personnel to effectively manage operations in Asia. Many industry analysts contend that the lower initial costs of Asia-based companies are usually offset by the money and resources need to oversee a project.

While business returning from Asia improved the financial outlook for some American CMOs, 2009 was a bad year for most firms that service small to mid-sized pharma and biotech companies. However, industry analysts expect 2010 to be better than 2009. More importantly, the return of biomanufacturing to the US may signal the beginning of a new trend in the biomanufacturing outsourcing industry.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

 

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Billy Tauzin, a former Congressman and high profile lobbyist, unexpectedly resigned as President of the Pharmaceutical Research and Manufacturers of America, (PhRMA), a pharmaceutical industry lobby and trade organization. According to a report in today’s New York Times, his resignation resulted from internal disputes over PhRMA’s pact with the White House to trade political support for favorable terms in the proposed health care reform bill. The trade group issued a news release on Thursday night confirming Mr. Tauzin’s departure, effective June 30.

When he first took the helm at PhRMA in 2005, Tauzin’s publicly-stated goal was to improve the group’s image and reduce the “number of its enemies.” Prior to Tauzin’s arrival at PhRMA, it was an obscure lobbying group that was little more than a “rubber stamp” for the agenda set by pharmaceutical companies. Under Tauzin's tutelage, the trade group adopted a more progressive strategy and tried to set a new agenda for the pharmaceutical industry.

In exchange for favorable terms in the original Obama healthcare reform package, PhRMA spent more than $100 million on ads to promote the overhaul. But after healthcare reform stalled, some industry leaders felt the trade group had gone too far giving concessions and could lose on some important legislative issues without gaining the political protection it had sought.

Despite publicly accusing the White House of reneging on its original deal, Tauzin’s willingness and zeal to help to reform healthcare ultimately led to his demise. I suspect that the next person chosen to lead PhRMA will likely be a pharma insider willing to "tow the party line."  While I wasn’t originally keen on Tauzin’s appointment, he proved to be an extremely effective  leader, who unlike most of his PhRMA predecessors, was forward-thinking and had a clear vision for the future of an industry currently in transition.

Tauzin’s departure signals that many pharma executives believe that healthcare reform is dead and companies can continue with “business as usual.” While failed healthcare reform may be beneficial to big pharma in the short term, it ultimately may lead to pharmaceutical price control legislation. This is because—in the absence of healthcare reform— drug and devices prices will continue to skyrocket and  legislators will have little choice but to regulate and cap drug and devices prices.

Until next time,

Good Luck and Good Job Hunting!!!!!!!

 

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In previous posts, I have mainly focused on job search strategies and behaviors designed to increase the likelihood of either getting a face-to-face job interview or a job offer. 

Today, I want to focus on behaviors and strategies that jobseekers must AVOID at all costs during a job search. In a CareerBuilder.com poll, more than 3,000 hiring managers and human resources professionals were asked to identify some of the more egregious mistakes that jobseekers (most notably recent college graduates) making during the application and interviewing process. Poll results per centages and associated commentary and advice were originally posted on the Pongo Resume blog.

1. Acting bored or cocky (69%)
This sounds familiar. We had someone interviewing at Pongo recently who seemed pretty good, but two or three people used the word "cocky" to describe the person's attitude. (Our managers, like those at many companies, solicit opinions from everybody who comes in contact with a job candidate, not just those in the interview room – hint, hint.) If you're a new college graduate, it's important to realize that you may have been the coolest kid on campus a few months ago, but today you’re an unproven beginner. A positive, respectful attitude is one way to set you apart. Confident = good. Cocky = bad.

2. Not dressing appropriately (65%)
Your interview attire, like your attitude, says a lot about whether you're serious about proving yourself, or just think you're entitled to the job because you're you. Your clothing should be clean, pressed, and modest. As they say in middle school, no visible boxers, bellies, or boobs.
 
3. Coming to the interview with no knowledge of the company (59%)
There's no excuse for not researching an organization that's considering hiring you. They have a web site; use it to learn what they do, who they are, what they specialize in. Google the executives' names (after all, they'll be Googling you; see #8, below). 

4. Not turning off cell phones or electronic devices (57%)
Frankly, I'm surprised this isn’t No. 1. If you accidentally leave your phone on and it rings during the interview, don't get flustered and start babbling, "OMG, I can't believe I did that!" Offer a brief, sincere apology, turn off the phone (without checking who it is), then carry on professionally as if nothing happened.

5. Not asking good questions during the interview (50%)
If you don't ask anything, you must not be interested. That's what the hiring manager will assume. This is a place where you supposedly want to spend most of your waking hours for the next couple years or more. You must want to know something. Besides, there are certain questions you should always ask.

6. Asking what the pay is before the company considered them for the job (39%)
Mentioning salary in a first interview is like asking your crush what s/he plans to spend on you during your relationship – before you've even agreed on a second date. You have to flirt and make sure they're attracted to you before you ask about a financial commitment.

7. Spamming employers with the same resume and/or cover letter (23%)
This guy John really, really wants to work for Company A, so he applies for every job opening Company A posts, whether he's qualified or not. Annoyed by John's never-ending resume spam, Company A's recruiters unofficially blacklist him (although if asked, they'll deny it). Don't be like John. Tailor your resume for the one or two jobs at your target company that align with your skills.

8. Failure to remove unprofessional photos/content from social networking pages, Web pages, blogs, etc. (20%)
Dude, you will be Googled. Employers today use every means at their disposal to uncover red flags that might foretell a bad hire. So, hide all Internet evidence of your past (and present) indiscretions.

While many of these not-so-smart behaviors may appear to be obvious, the percentages of new jobseekers who engage in them would suggest otherwise. The job market is extremely tight at the moment and the competition for jobs is the fiercest it has been in last 50 years. Don’t give hiring managers an excuse to not hire you by engaging in the above mentioned behaviors and practices!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Despite the announcement late last week in the London Sunday Times that GlaxoSmithKline (GSK) will eliminate 4000 jobs worldwide, company official are refusing to disclose the number of worker who will lose their jobs in the US. Cuts are expected throughout the US including GSK’s R&D facilities in the Philadelphia, PA area and at its US headquarters in Research Triangle Park, NC which employs roughly 5,000 people.

GSK officials typically refuse to share detailed information on how layoffs affect its Triangle work force. Nearly a year ago, the company cut an undisclosed number of workers at a customer response center in RTP. GSK announced a first cost-cutting initiative in October 2007, eliminating thousands of jobs worldwide, and then it expanded that effort in February 2009 with many hundreds losing jobs at it North Carolina facilities in RTP and nearby Zebulon.

This coming Thursday is expected to be pink slip day at GSK.

Until next time....

Good Luck and Good Job Hunting (forget RTP)!!!!!!!

 

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It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"...the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21^st century technology continues to unfold.

Hat tip to Natalie!

Until next time...

Good Luck and Good Tweeting!

 

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Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on John Crowley’s ongoing crusade to find a cure for Pompe Disease a genetically inherited illness that afflicts two of his three children.The film chronicles the 'extraordinary measures' taken by Crowley to find a treatment for the so-called orphan disease that affects the lives of about 40,000 persons worldwide. While I haven’t seen the film, it bears a striking resemble to the 1992 film “Lorenzo’s Oil” which chronicled the struggles of two parents to find a “cure” for their son’s adrenoleukodystrophy an another orphan disease.

Crowley’s story began about 12 years ago when his oldest child was diagnosed with Pompe Disease. For those of you who may not know, Pompe Disease is a progressive, multisystemic, debilitating, and often fatal neuromuscular disorder. The disease is linked to an inherited deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA), which is responsible for the breakdown of glycogen inside the cells. The result is intralysosomal accumulation of glycogen, primarily in muscle cells, that leads to a progressive loss of muscle function and ultimately death. At the time of the diagnosis, Crowley, a Princeton, NJ resident, was working as a marketer for Bristol Myers Squibb. He quickly learned that there was no effective treatment for Pompe Disease and that his daughter may not live beyond early childhood. Further, because the disease afflicted so few individuals, no pharmaceutical or biotechnology companies were working on treatments for Pompe Disease. 

To stave off the likelihood of his daughter’s death, in 2000, Crowley raided his 401k plan and mortgaged his home to start a company called Novazyme that focused exclusively on developing treatments for Pompe Disease. Having no time to waste, Crowley and the Novazyme team worked feverishly to develop an alglucosidase alfa enzyme replacement therapy for Pompe. By 2001, the Novazyme team had identified a likely treatment and Crowley sold his company to Genzyme. As a senior vice president at Genzyme, he oversaw clinical development of the product which is now called Myozyme and is the first FDA-approved treatment for Pompe Disease. Crowley left Genzyme in 2004 and is currently CEO of Amicus Therapeutics a 100 person company focused on developing new treatments for Pompe Disease and other orphan indications.

At present, there are no other treatments besides Myozyme for Pompe Disease. This is because Pompe Disease is designated as an orphan indication and Genzyme received seven years of market exclusivity for Myozyme as stipulated in the Orphan Drug Act. Myozyme received FDA approval in 2006.

While Genzyme has been the only player in the Pompe Disease market for the past four years, manufacturing and scale up problems threaten to jeopardize the Myozyme franchise. Genzyme’s highly publicized problems at its Allston, MA-manufacturing facility have been well documented and Genzyme’s management team is taking bold steps to correct them (including hiring a new senior vice president for global product quality) and entering into an agreement with Hospira Worldwide Inc to provide fill and finish manufacturing services.

But perhaps more troubling, were the problems that the company experienced when attempting to scale up Myozyme production from the 160L to 200L bioreactor scale to meet growing demand for the drug.  FDA informed Genzyme that that Myozyme® (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. And, the company would have to file a new biologics application (BLA) for the 2000L product to garner regulatory approval.

Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale (now marketed as Lumizyme). Lumizyme has already been approved in more than 40 countries. However, manufacturing problems and violations at the Allston facility forced FDA to delay a decision on the approvability of Lumizyme this past March. Earlier this week, Genzyme announced that FDA will issue a new decision on Lumizyme in June.

While originally spurned by large drug companies, orphan drug development is becoming much more attractive because of the lack of new blockbuster drugs in most company’s development pipeline. According to a recent report, the number of orphan product designations in the US more than doubled in the last decade rising from 208 in the 2000-02 periods to 425 in 2006-08. More recently, Pfizer, the world’s largest pharmaceutical company announced that it agreed to pay at least $60 million for rights to Protalix Biotherapeutics Inc.'s new treatment (taliglucerase alfa) for Gaucher’s Disease another orphan indication. This suggests that Pfizer has made a decision to directly compete with Genzyme, the world leader in orphan drug development.

Don’t be surprised when other large pharmaceutical and biotechnology companies announce plans to compete in the orphan drug market...there is money to be made!

Until next time...

Good Luck and Good Job Hunting!!!

 

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Last week, the market-analyst firm Manhattan Research released a list of the top branded pharma Web sites based on traffic generated from direct-to-consumer (DTC) television ads. The firm tracked about 250 different product sites and asked 6,575 consumers which websites they visited in the past 12 months. Consumers were asked to recall the reason they visited the site, whether they are taking the product, think they need the product, and the actions they took after they visited the site. The following list represents the top ten product websites that were more likely to have website traffic driven by DTC television ads. However, it is important to note that the rankings are not based on the volume of traffic but the percentage of traffic generated in response to integrated DTC advertising campaigns.  

1. NuvaRing—Merck (formerly Schering Plough formerly Organon)
2. Latisse—Allergan
3. Cialis—Lilly
4. Boniva—Roche
5. Abilify—Bristol Myers Squibb
6. Gardasil—Merck
7. Yaz— Bayer
8. Viagra—Pfizer
9. Levitra—Eli Lilly
10. Lunesta—Sepracor

Interestingly, of the top ten products on the list about 70% of them have to do with sex or woen's reproductive health. The exceptions include Abilify (depression and bipolar disease), Lunesta (insomnia) and Latisse (eyelash growth). Pfizer, Levitra and Cialis are treatments for ED, Gardasil is an anti-cervical cancer vaccine, Boniva is used to treat osteoporosis (post menopausal women) whereas Yaz and NuvaRing are both used for birth control.

I thought the results of the survey where interesting because many experts say the effectiveness of DTC television advertising may be waning with the growing use of online resources. While the results of this survey are not conclusive, it suggests that DTC television advertising won’t be going away anytime soon. And that the growing use of televisions as web portals may actually increase not diminish industry’s reliance on DTC television ads to sell its product and treatments—oy! 

Hat tip to George Koroneos at the PharmaExec.com blog.

Until next time...

Good Luck and Good Watching!!!!!!!!!

 

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I previously posted several articles on interviewing tips. This presupposes that many of my readers have made the first cut and have been invited to participate in a phone or face-to-face onsite job interview. Unfortunately, this isn’t any easy thing to do in today’s current employment market. Nevertheless, there are a variety of things that job seekers can do to help their application standout from the hundreds (thousands) of other applications submitted by others competing for the same position. To that end, I found an article that first appeared on the JobsJournal.com website that offers basic tips on how to design a resume (and accompanying cover letter) to distinguish individual jobseekers from their competition.

While the information contained in the article isn’t “game changing” it does offer fresh insights into how job candidates must position themselves to be noticed in today’s fierce and highly competitive job market.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!

 

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As Jonathan Richman, author of the Dose of Digital blog focused on pharmaceutical marketing aptly put it, its time to “stop talking about social media.” “To recap, in 2009 we demanded the FDA call a hearing to discuss social media…and they did! We wrote and read hundreds, if not thousands, of articles on social media. We transformed (read: hijacked) every digital marketing conference into a social media conference. We launched a ton of social media programs even if they represent a conservative start.”

While I am still an ardent social media enthusiast and supporter, I agree with Jonathan that it may be time to sit back, relax and reflect a little bit until FDA enlightens us with their first round of guidance on social media and the life sciences industry. Having said that, I am certain that the agency’s first iteration will provide us bloggers with sufficient fodder to write about and ignite round 2 of the discussion. In the meantime, @Skypen of Ignite Health graciously created a website called Everything About the FDA, Internet & Social Media that provides updates, commentary and even tweets (#FDASM) about FDA progress or lack thereof.

I think that social media has a role to play in the life sciences industry. However, the role has yet to be defined mostly because of the lack of regulatory guidance in the area.

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

 

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I am frequently asked by graduate students and postdoctoral fellows who are having trouble finding a research and development job, whether or not it makes sense to go to business school to get an Masters of Business Administration) MBA degree to enhance their business acumen. While I don’t think it would hurt (especially if you are interested in business), I also don’t think most scientists benefit from enrolling traditional MBA degree programs. With this in mind, some forward-looking academic institutions have launched joint PhD-MBA programs which allow students enrolled in these programs to graduate with PhD and MBA degrees at the end of their graduate training.

The joint programs typically take less time than it would to earn each of the degrees individually and mainly cater to scientists who have decided to eschew academic science careers in favor of life sciences management jobs. While these programs are relatively new and continue to evolve, growing numbers of would-be scientists who are also interested in business are taking advantage of them.

One of these students, Kristy Houck graduated with a PhD in pharmacology and a MBA from the Pennsylvania State College of Medicine joint program almost two years ago. “I loved science, but knew that I didn’t want to perform bench work for the rest of my life. This opened a world of career opportunities for me” said Houck. “Previous graduates of the program have quickly risen to management level positions because they are recognized as business-savvy scientists” she added.

Other academic institutions are closely watching these programs to determine whether or not graduates of the joint PhD-MBA programs have better employment outcomes as compared with person who go through traditional PhD and MBA graduate programs. I listed the institutions that currently offer the joint program in the table below. Check it out!

Academic institutions that offer joint PhD/MBA program in the life sciences

Name of Institution                                                   Website
Dartmouth	http://su.pr/2udGyO
Pennsylvania State University (Dept. of Pharmacology)	http://su.pr/21CRWm
San Diego State University	http://su.pr/2hqX8y
University of Connecticut	http://su.pr/4LQ6Dt
University of Florida	http://su.pr/2ltSSj
Vanderbilt University	http://su.pr/9Ze6Uf
Wake Forest University	http://su.pr/As4gip

Until next time....

Good Luck and Good Job Hunting!!!!!!

 

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Just when you thought that holding on to a job couldn’t get any worse, Pfizer formally announced yesterday that it would be eliminating 680 jobs from a combined workforce of 4,500 at two former Wyeth facilities in Pennsylvania. According to a company spokesperson, 450 of the layoffs would come from Collegeville and 230 from Great Valley. They will take effect March 12. Persons affected by the layoffs will each qualify for a separation package that will include severance payments, continued medical benefits, and help finding a new job via outplacement services.

While some layoffs were expected, they were much greater than some state legislators were led to believe in earlier discussions with Pfizer. And this isn’t likely to be the end of corporate reorganization at Pfizer PA-based facilities. This is because Pfizer is shutting down the Great Valley facility. There is speculation that after this round of layoffs that the 670 remaining Great Valley employees will be transferred to the Collegeville site or other Pfizer locations. And, it is likely that more Pfizer employees will lose their jobs because Pfizer previously announced that it intended to eliminate as many as 15% or 20,000 jobs after its $68 billion acquisition of Wyeth.

Over the past several months, Pfizer, Eli Lilly, AstraZeneca, Johnson & Johnson and GlaxoSmithKline have announced more than 40,000 job cuts which have devastated the pharmaceutical workforces in Pennsylvania, New Jersey and Delaware. 

Until next time...

Good Luck and hmmmmmm...are there any pharmaceutical jobs left to hunt for?

 

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For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with Steve Projan— a well known and highly respect maven on bacterial antibiotic resistance—who told me that the physician story was an urban legend and that the main reason for the emergence of antibiotic resistance was directly related to the use of antibiotics as growth enhancers in livestock feed. Not surprisingly, shortly after my conversations with Dr. Projan, papers began appearing in the literature that corroborated the claims.

Despite a growing body of convincing scientific evidence, the Bush administration did nothing to regulate or reduce the use of antibiotics in live stocks feeds in the US for almost a decade. Last year it is estimated that 35 million pounds of antibiotics were used in the US. Interestingly, 70% were used in cows, chickens and pigs. It is important to point out that the US isn’t the only culprit; recent estimates suggest that 50% of the global antibiotic supply is used by the livestock industry. Recognizing a growing problem, the European Union and other developed countries (not the US) have adopted strong limits on the use of antibiotics for livestock purposes.

Thankfully, the pressure against the use of antibiotics in agriculture and livestock production is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health — the Food and Drug Administration (FDA), CDC and U.S. Department of Agriculture — declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And, this past summer, FDA deputy commissioner Dr. Joshua Sharfstein told Congress that farmers need to stop feeding antibiotics to healthy farm animals.

Pharmaceutical companies and agricultural lobbyists argue that antibiotics keep animals healthy and meat costs low, and have successfully help to defeat a series of proposed limits on their use. To that end, in 2009, drug makers spent $135 million and agribusiness companies another $70 million, lobbying against new limits on the use of antibiotics as livestock growth enhancers. FDA official say that without new laws the agency’s options are fairly limited. Ironically, the agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. And, the only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

Previous attempts by FDA to limit antibiotic usage have consistently met with limited success. For example, in 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups. In 2000 FDA ordered the antibiotic Baytril (used in the poultry industry) off the market. Five years later, after a series of failed judicial appeals, poultry farmers finally stopped using the drug as a growth enhancer. Finally, in 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration — in an FDA note in the federal register — reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Luckily, we now have a President who believes in regulation of big business to protect the health and welfare of Americans and is smart enough to make the scientific connections between emerging antibiotic resistance in animals and human. Maybe some real change will be coming soon....one can only hope!!!!!!!!!!

Hat tip to Ed at the Pharmalot Blog

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Governor Deval Patrick and the Massachusetts Life Sciences Center announced today that the Center’s Board of Directors has awarded $25 million in Tax Incentives to twenty-eight life sciences companies. The companies receiving tax incentive awards have committed to creating a combined 918 new jobs in the Commonwealth over the coming year. The companies that received awards include many of state’s largest biotechnology companies e.g. Biogen, Genzyme, Sepracor and Cubist, as well as some smaller private and public ones (see below) 

1. Alnylam Pharmaceuticals, Inc. (Cambridge) — $300,000
2. Biogen Idec MA, Inc. (Cambridge) — $1,500,000
3. Constellation Pharmaceuticals, Inc. (Cambridge) — $513,252
4. Cubist Pharmaceuticals, Inc. (Lexington) — $1,740,000
5. Dyax Corporation (Cambridge) — $100,000
6. Facet Solutions (Hopkinton) — $300,000
7. FoldRx Pharmaceuticals, Inc. (Cambridge) — $510,000
8. Genzyme Corporation (Cambridge/Framingham) — $6,000,000
9. GTC Biotherapeutics, Inc. (Framingham) — $300,000
10. Hologic, Inc. (Bedford) — $220,000
11. Infinity Pharmaceuticals, Inc. (Cambridge) — $540,000
12. InfraReDx, Inc. (Burlington) — $630,000
13. Interlace Medical, Inc. (Framingham) — $300,000
14. Lightlab Imaging, Inc. (Westford) — $188,951
15. Merrimack Pharmaceuticals, Inc. (Cambridge) — $1,500,000
16. Morgan Advanced Ceramics, Inc. (New Bedford) — $570,000
17. NeuroMetrix, Inc. (Waltham) — $300,000
18. Nova Biomedical Corporation (Waltham) — $300,000
19. OmniGuide, Inc. (Cambridge) — $540,000
20. Organogenesis (Canton) — $245,240
21. Pharmasphere, LLC (Worcester) — $360,000
22. Sepracor, Inc. (Marlboro) — $750,000
23. Shire Human Genetic Therapies, Inc. (Lexington) — $6,277,057
24. STD Med, Inc. (Stoughton) — $121,000
25. Still River Systems, Inc. (Littleton) — $300,000
26. TEI Biosciences, Inc. (South Boston) — $27,000
27. Tolerx, Inc. (Cambridge) — $300,000
28. Zoll Medical Corporation (Chelmsford) — $267,500

While the tax breaks are a great way to insure that the 28 companies that received them will remain and continue to do business in Massachusetts, creation of only 918 new jobs in exchange for $25 million in tax incentives doesn’t seem fair to me! I guess beggars (state governments) can be chooser in the current economic climate.

Until next time...

Good Luck and Good Job Hunting (try MA, there may be one or two opportunities there)

 

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Mark Senak who writes the EyeonFDA blog has compiled a list of the life sciences companies that presently have a Twitter account and use it. While there are only 12 companies on the list, he provides a nice commentary on their use and makes some recommendations for improvement.

Although I am a staunch supporter of the use of social media in the life sciences, it appears to me that the discussion about its use has been somewhat muted since the FDA convened a public hearing on the topic last month. I suspect that many of the companies and stakeholders who participated in the discussion prior to the FDA meeting are presently in “wait and see” mode. However, don’t be surprised if the social media guidance issued by FDA is lacking and excruciatingly wanting!!!! For those of you who may not be familiar with the ways in which the agency operates, its regulators tend to craft guidance and regulation that are broad, loosely defined and open to interpretation. The agency intentionally crafts its guidance and regulations this way because it doesn’t want its rules and regulations to be “literally interpreted” by companies and other stakeholders. Generally speaking, its regulations represent the “minimum” requirements that must be met in order to insure regulatory compliance. In other words, there is no upper limit on what companies can do to insure compliance but there certainly is a minimum requirement that must be met to avoid regulatory sanctions and penalties. As one lawyer who used to work for the agency shared with me recently, “FDA crafts the regulations but it is left to the companies and courts to interpret them.”

Most of the current discussions about social media and the life sciences industry primarily focus on its use as marketing and promotional vehicle. And, as many of you may already know, FDA isn’t exactly keen or pleased with the current marketing and advertising strategies and practices utilized by a sizeable number of life sciences companies. Perhaps a shift away from marketing and advertising discussions to more regulatory-friendly and practical applications like clinical trials recruitment and public outreach may lead to a more rapid uptake of social media by FDA and life sciences companies? Just sayin’

Until next time...

Good Luck and Good Tweeting!!!!

 

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In a previous blog post, I raised the possibility that the life sciences industry may be using adverse event (AE) reporting to explain why it has been slow to adopt social media as a means of communicating and interacting with its customers and stakeholders. The industry argument against social media goes something like this: by engaging physicians, consumers and other stakeholders in social media conversations, there will be a massive and unmanageable explosion of AEs posted to social networking sites, company websites and health and science blogs. Because of this, companies will be obliged to report them to FDA. Company executives’ fear that this will be inordinately expensive, egregiously time-consuming, technologically-daunting and most importantly, expose companies to possible legal and regulatory actions. While some of these claims may have some validity, they are not as expensive, technologically-challenging or insurmountable as anti-social media advocate would have you believe. For example, while conducting an interview for Life Science Leader magazine for an article on social media and pharma, several pharma employees exploring the social media space confided that most companies already have assiduously-crafted AE reporting policies in place to easily manage and accommodate AE reporting from  websites, cell phones and even text messages! For those of you who may be wondering, before potential AEs are required to be reported to FDA it must meet the following criteria: (i) there is an identifiable patient; (ii) there is an identifiable reporter or observer; (iii) there is a specific drug or biologic involved in the event; and (iv) there is an adverse event or fatal outcome.

Jonathan Richman (social media guru and pharmaceutical marketing expert) and I have previously weighed in on the so-called “adverse event reporting myth” that has been circulating in life sciences social media circles. In fact, I posited in my previous post that adverse event reporting may actually be something of a “red herring” being used by the industry. For those of you who may not be familiar with the term, it means focusing on an obvious and easily identifiable issue or object to draw attention away from a more important central issue.  To that end, I was pleased to read a post today on Jonathan’s Dose of Digital Blog entitled 166 Reportable Adverse Events Equals One Red Herring.

In today’s post, Jonathan does some basic mathematical calculations and arrives at the conclusion (based on the occurrence and frequency of Internet-based adverse events disclosed in a recent Nielsen survey) that the likely number of adverse events posted on social media sites per day would be around 166 (for the entire industry). Doing some of my own high-level mathematical calculations; this translates into a likely total annual number of about 60,590 AEs. And, as Jonathan rightly points out, if this number is divided by the number of life sciences companies with approved drugs and devices on the market, you quickly realize that shouldn’t be that onerous, labor intensive or expensive for companies to manage AE reporting resulting from social media sources. It would be interesting and informative to compare this annual rate with the actual number of reportable annual adverse events being handled by life sciences companies today. 

Like Jonathan, I believe that the “adverse event reporting issue” is a classic example of a “red herring” being employed by the life sciences industry to explain its reluctance to jump on the social media bandwagon. Personally, what I believe is really at stake, is the systemic changes that would be required to transform a historically, opaque and unresponsive industry into a transparent, accountable and responsive one that would be required if it embraces social media as an integral part of its business model.  

Addendum:  Shortly after posting this article, a new post appeared on the Dose of Digital blog that provided an indepth analysis of the Nielsen survey and its implications.

Until next time...

Good Luck and Good Job Hunting!!!!

 

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Losing a job or getting laid off is without a doubt one of the more emotionally devastating events that most people face. Unfortunately, in these troubling financial times, many more people are likely to face this likelihood than any other time in recent history.

However, if you lose or have lost a job, it is important to keep your situation in perspective and realize that it isn’t the end of the world and that there are things that you can do to find a new job! Having said that, like most other things in life you will have to work hard to achieve that goal! This will require organization, commitment and dedication to the job search. And, the best way to conduct a successful job search is to approach it and treat it like a full time job! To that end, attempt to divide each day into manageable list of tasks and allocate sufficient time to accomplish them—just like you would at a full time job. Also, since time is usually no longer an issue, you can spend some of your time researching new opportunities, networking with others or finding new contacts who might be able to help you get your foot in the door at a prospective employer’s company or organization.

Sitting in front of a computer all day, applying for online jobs on company websites and job boards isn’t going to cut it—mostly because you won’t hear back from most of the places where you submitted online job application. In fact, I think that the online approach to job hunting almost guarantees that you will become dejected, depressed and hopeless. 

In my opinion, the best approach to a job search (after losing a job) is to recognize that anything less than full time commitment to finding a new one likely won’t be successful. Based on my own and other’s experience, a successful job search consists of a mixture of focused and disciplined online and IRL activities. Developing and implementing an ordered and strategic job search provides jobseekers with organization and a “structure” that will likely help to ward off feelings of confusion, dejection and hopelessness experienced by most people who have lost jobs. For more ideas and suggestions on how to transform your job search into a full time job please check out this excellent article by Phyllis Korkki.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!

 

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Much has been written about how supportive the pharmaceutical industry has been about US healthcare reform. Prior to the debate, the Obama administration gleefully announced that pharma will give $80 billion in drug discounts in exchange for certain assurances that weren’t publicly disclosed. As most of us know, the US House of Representatives passed historic healthcare reform legislation last week and in addition to a public option it stipulates that pharma will be required to give $140 billion in drug discounts. According to Ed Silverman over at the newly reinstated Pharmalot blog, AstraZeneca CEO David Brennan, who is also this year’s chair of the industry trade group PhRMA, vowed that pharma would fight the house healthcare reform legislation. 

While Brennan’s statement isn’t surprising nor particularly noteworthy, his comments explaining pharma’s position on healthcare reform are revealing and important to understand. He told the Huffington Post “We said there were principles we didn’t want to see violated. And if those principles - price controls, Medicare rebates, moving dual eligibles back from Medicare and back into the Medicaid discount program - if those things happen, I can’t see how we could be supportive of the program.” In other words, we will support anything you propose— and may even be willing to kick in another $60 billion or so to support healthcare reform— but any discussion about government regulation of drug prices is a deal breaker! 

To my knowledge, this is the first public mention of price controls by any pharmaceutical executive during the almost year long debate on healthcare reform. The reason that I find Brennan’s statement interesting is that I have long contended that pharma will give the Obama administration and Congress anything it wants in exchange for assurances that the government will not attempt to control drug prices. For those of you who don’t know, the US is one of the only countries in the world where the government is prohibited from setting drug prices. This means that US drug makers in concert with insurance companies and third party payors can set drug prices based on what the American pharmaceutical market can bear. Not surprisingly, the profit margins on drugs sold in the US are the highest in the world. Obviously, pharma doesn’t want the US government hindering or limiting their profits by setting or capping drug prices. 

I am glad that pharma has finally decided to publicly “come clean” on the price control issue. The public option and issues surrounding data exclusivity for follow-on biologics pale in comparison to the financial havoc that price controls would wreak on the pharmaceutical industry. And, I suspect that pharma and its lobbyists will do whatever it takes to insure that price controls never become a reality in the US. However, at the end of the day, government regulation of drug and device prices will ultimately be required for any meaningful changes to take place to the US healthcare system.

Hat tip to Ed!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

Addendum: After writing this post this weekend, an article appeared in Monday's New York Times that revealed that the drug industry has quietly been raising its wholesale prices on prescription drugs over the past year.  This, of course, was done in anticipation of possible federal legislation that might impose some government controls on drug pricing.  According to the Times article: "In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992. The drug trend is distinctly at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year.  Not surprisingly, the US pharmaceutical industry justifies the practice because as an industry spokesperson put it  "they are having to raise prices to maintain the profits necessary to invest in research and development of new drugs as the patents on many of their most popular drugs are set to expire over the next few years."  Hmmmm, interesting comment considering the US pharmaceutical industry has layed off over 180,000 employees over the past three years, a majority of whom are R&D scientists...go figure!

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Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Employees of Pfizer/Wyeth were notified earlier today of impending changes and consolidation that will be taking place at the newly combined company. According to internal sources, Cambridge, MA, Groton, CT and Pearl River, NY will be the main centers of the combined company’s East Coast operations and San Francisco and La Jolla/San Diego CA will represent West Coast operations. In Europe, the research facility in Sandwich, England will be the main R&D center with a network of smaller sites, in locations such as Montreal, Ottawa, Cambridge UK, Aberdeen UK, and Dusseldorf, Germany providing expertise in vaccine production and biomanufacturing. The company’s China R&D Center in Shanghai will remain the focal point of operations in Asia,

There will be substantial reductions in headcount and the company’s R&D footprint. These include:

• The former Pfizer headquarters in New London, CT, which will be consolidated into the nearby Groton, CT site. Functions currently located at New London will be relocated to Groton
• Elimination of all R&D activities at Princeton, NJ; Sanford and the Research Triangle Park, NC; Chazy, NY; Rouses Point and Plattsburgh, NY; Gosport, Slough and Taplow, UK
• R&D activity will be substantially reduced at the Collegeville, PA and Pearl River, NY sites. Pearl River will remain a center for vaccine and biopharmaceutical development

I suspect that many of the employees who will lose their jobs as a result of the consolidation have already been or will be notified shortly of their fates. It is unfortunate that pharmaceutical companies continue to lay off thousands of employees when the US unemployment rate continues to rise and will likely hit 12 to 13 percent before it is all said and done. As expected, the combined company is reducing its US R&D operations and will likely outsource or purchase these activities from external sources. It is not a good time to be an American R&D scientist.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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For the past several weeks, the EyeonFDA blog has been reporting on the possible regulatory impact of Google’s Sidewiki on life sciences companies. For those of you who may not be familiar with Sidewiki  (released in late September) it is a new feature of the Google toolbar which can turn a static web 1.0 website into an interactive web 2.0 experience by allowing website visitors to leave comments behind.

When you use side-wiki, you have the ability to leave your comments and associate them with a website whether or not the website owner has enabled commenting.  Since the comments are maintained by Google, there is no direct relationship with the website.  Basically, anybody who visits a website that has Sidewiki enabled can say or comment on whatever they like and immortalize it (until Google removes it) for the entire world to see. Apparently, this doesn’t sit well with many website owners and Google purportedly recently release code to disable Sidewiki at websites that don’t want to support it. However, it isn’t clear how robust the anti-sidewiki code is!

While I haven’t formulated an opinion on Side Wiki yet (mostly because it isn’t that interesting to me), it does represent a regulatory dilemma for life sciences companies with marketed drugs and devices. According to today’s EyeonFDA post “If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page.  Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so?  It is a conundrum - and there is no insight apparent from the FDA on the matter.” Further, most life sciences companies have yet to craft a legal or regulatory policy for Sidewiki usage. 

EyeonFDA has been assiduously monitoring life sciences company websites for the appearance of Sidewiki. To date EyeonFDA has found it on the following company websites:

1. Abbott
2. Amgen
3. AstraZeneca
4. Bayer
5. Baxter
6. Bristol-Myers Squibb
7. GSK
8. Johnson & Johnson
9. Lilly
10. Novartis
11. Novo Nordisk
12. Pfizer
13. Roche
14. Sanofi-Aventis
15. Takeda

While Google would like everyone to believe that Sidewiki is taking the Internet by storm and spreading like the H1N1 virus, a show of hands at yesterdays e-Patient Connections 2009 meeting in Philly, which was attended by many computer geeks and social media enthusiasts, revealed that about4 out of about 150 had heard of it! Nevertheless, it is out there and life sciences companies would be well advised to formulate internal legal and regulatory guidelines despite the fact that FDA hasn’t issued any guidance on its use.

P.S. Shortly after I posted this, @pharmaguy alerted me to an article that appeared on the today's online PharmaExec.com entitled "SideWiki: What's Pharma To Do"?

Until next time...

Good Luck and Good Commenting

 

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Whenever I do resume critiquing at scientific meetings, someone always asks about how to negotiate a job offer.  Most of the people that ask the question aren't even close to receiving a job offer and I do my best to deflect the question.  However, at a recent meeting, I spent 30 minutes with a PhD student who had received an offer advising him on how to get a better deal from his prospective new employer.  This got me thinking and I invited Joe Tringali, a veteran recruiter with lots of negotiating experience to write a blog post about strategies and things to consider when negotiating a job offer.

The "Dos" and "Don'ts" of Negotiating a Job Offer

by Joe Tringali

Invariably, the topic of salary negotiations in the interview process makes its way to the surface and, as a seasoned professional recruiter, I have a few thoughts that I would like to share with jobseekers.  During the course of my almost 30 year career, I have work as a traditional “headhunter” and also as on onsite contract recruiter for pharmaceutical and biotechnology companies, shifting gears and mindset as warranted by the particular client and the task at hand. In other words, I have been on both sides of the negotiating table either on behalf of a job candidate or a client company.

Fundamentally, job seekers need to understand the “economics” surrounding their search; who—the candidate or employer—has the most leverage in the relationship? Is there more demand than there is supply for a candidate with a specific set of skills or is there an excess of talent allowing an employer to choose the absolute best candidate for job. That said, consider the following:

A candidate who has received an offer can always try to negotiate to see how far they can push  the employer. As a rule of thumb, the initial offer that is proffered is usually not the best offer and if you aren’t satisfied with it, try and negotiate for a better deal.  If you ask and you don’t get what you want, the initial offer will likely still stand but you won’t have any regrets or say to yourself “I should have asked” if you eventually accept the offer. On the other hand, if the offer IS negotiable, it’s most likely only negotiable within a finite range. To that end, you must “come to the table” knowing your worth and what the compensation and benefits standards are for comparable positions in the industry. Rest assured that the prospective employer is at least as prepared as you are (usually more so) when it comes to negotiating offers. After all, most companies have dedicated compensation departments that spend a good portion of their workweek establishing fair compensation ranges. This doesn’t mean that you shouldn’t ask and attempt to negotiate, but simply that you must temper your expectations and not “expect the world.” Typically, employers are limited with what is negotiable in an offer. Things that are typically not negotiable are base salaries and healthcare and financial benefits. Other things like vacation time, sign on bonuses, relocation costs etc are. The reasons why base salary and benefits are not negotiable are because companies try to maintain internal equity among its employees.

When to negotiate? The obvious answer is to negotiate from a position of strength—when a formal offer has been extended (but never before). The offer signals that a company “wants you” and the candidate ought to consider the offer as it stands. Assuming the offer is fair (and the candidate SHOULD know his/her worth as part of the search process), accept it and move on with your career. Should you feel it isn’t quite up to par based on your understanding of your skills and marketplace demand, you might consider a conversation that sounds something like the following:

“I’m thrilled to receive the offer and am trying to find a way to make this work for both parties. My understanding of the market ( from online research, university career services, friends with similar experience, in similar roles, in similar geography,  is that an offer of 2k more might be more in line. IF there is any way you can bump the offer up by 2K, I will accept it and start on XXX date”

In other words, you are offering something back (acceptance/start date) in exchange for a possibly bump in the offer (most companies want you to start sooner rather than later). The worst case is that the employer comes back and says they cannot do any more with regard to compensation. Depending upon your assessment of the situation, you might then try to negotiate additional vacation days or an increase in relocation costs to offset the $2K that you need to feel comfortable to accept the offer. If the answer is still no, the original offer stands until you either accept or reject it—the decision is yours. Generally speaking, most offers are fair and in the range you might expect given your background and years of experience in the industry. But, only you can determine whether or not an offer is right for you. Ultimately, that decision ought to be based on compensation requirements, job responsibilities, geography, and whether or not an offer will meet your needs at this particular time in your life.

Until next time...

Good Luck and Good Job Hunting!!!!!

Joe Tringali is a Principal with Tringali & Associates, Inc., a recruitment consulting practice based in Manchester, New Hampshire. He has over 30 years of progressive experience in the field of Human Resources and is particularly well-qualified in the design and implementation of creative staffing programs and executive search practices within the Life Sciences. Some his clients include Pfizer, Eisai Pharmaceuticals, Millennium Pharmaceuticals, Biogen Idec, Genzyme , TKT/Shire , Harvard University and Infinity Pharmaceuticals.

 

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The fourth quarter is over, earnings are being announced and new budgets for the upcoming fiscal year are being evaluated and tweaked. This means that we have officially entered layoff and closure season. Isn’t it great that big companies wait until right before the holiday season to let employees know whether or not they will have a job next year?

That said, two companies, Bristol Myers Squibb (BMS) and Pfizer/Wyeth are the first to kickoff the 2009-2010 season.

BMS announced that it will lay off 25% of its Abilify sales force. This comes only six months after the drugmaker extended its contract with Otsuka Pharmaceutical to market the anti-psychotic and depression drug. Abilify is BMS’s second best selling medication after Plavix that is co-marketed with Sanofi-Aventis. Otsuka developed the drug and BMS markets and distributes it in the US and several European counties.

Abilify loses patent protection in 2012 and faces stiff generic competition in the anti-psychotic and depression markets. A BMS spokesperson declined to say exactly how many reps would be losing their jobs. However, according to a post on the sorely missed and recently resurrected Pharmalot blog there is speculation that Otsuka may hire some of the layed off BMS reps.

In other news, Pfizer/Wyeth announced that it will be closing its facility in Bridgewater, NJ but expanding operations at its Peapack-Gladstone, NJ location. The Bridgewater facility employs 300 people, 100 of which are involved in technology.  The company announced yesterday that it wouldn't be shutting down Wyeth's Collegeville, PA headquarters.

Over 120,000 employees have been laid off by pharma companies in the past three years, many of whom lived and worked in New Jersey.  Unemployment in NJ is hovering around 10%.

Stay tuned for more updates.

Hat tip to Ed at Pharmalot

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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An annual survey conducted by Science magazine and the American Association has identified the 2008 top twenty life sciences employers in the world. The rankings were based on a company’s leadership, stability, social responsibility and treatment of its employees. Six of the top 10— Genentech, Gilead Sciences, Genzyme Corp., Schering-Plough Corp., Gilead Sciences are based in the US whereas the remaining four—Boehringer Ingelheim, Roche Pharmaceuticals, EMD Serono, and Millennium are headquartered outside of the US. For the first time, eight of the top 20 are located outside the United States.

In case you were wondering, Genentech was ranked number 1. This is the fifth time out of the past 6 years that the San-Francisco based company made it to the number one slot (it fell to second last year). Another notable is Massachusetts-based Genzyme which made it to the number 3 spot (out of 575 companies) for the second consecutive year. Surprisingly, Monsanto, the company that makes genetically modified seed crops, was number 2—this despite all of the negative press about genetically modified foods. Let see whether or not Genentech can retain its number 1 ranking after the Roche takeover of the company is completed.

Until next time....

Good Luck and Good Job Hunting!!!!!!!

 

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For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!

 

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Mark Senak at the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) is seeking public input on the use of social media in the pharmaceutical, biotechnology and medical devices/diagnostic industry. Meetings to solicit input will be held in Washington DC on November 12 and 13^th.  This will be the first opportunity for industry representatives and the public to begin a discussion with FDA on the policies that will guide the use of social media in the life sciences industry.

According to EyeonFDA, on Monday, the agency will publish a notice in the Federal Register announcing this historic event (see excerpt below)

Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties. It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue. The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter; and on the topics outlined in the following paragraphs. We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.

For the past year or more, many bloggers and other social media enthusiasts have taken FDA to task for not taking action on the topic. Finally, the agency realized that something had to be done given the growing use and popularity of social media tools and strategies in other less regulated industries. Earlier this week, in an unexpected move, FDA launched its first Twitter feed. Perhaps this was a hint that FDA is beginning to emerge from the dark ages into the digital world of Web 2.0 and social media.

Hat tip to Mark!

Until next time...

Good Luck and Good Twittering !!!!!!!

 

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Eli Lilly & Co announced today that it is eliminating another 5,500 jobs or roughly 14% of its global workforce over the next two years. This would reduce to size of Lilly’s worldwide workforce from 40,500 to 35,000 by 2011. In addition to the job cuts, the company is reorganizing itself into 5 business units and hopes to save about $1.0 billion in annual costs.

These newly announced job cuts come after the company eliminated 4,000 sales representative jobs this past August and restructured its sale force. Also, prior to the recent cuts, Lilly launched the Lilly Phenotypic Drug Discovery Initiative or PD² a new program to ostensibly strengthen relationships with academic institutions to speed drug discovery and thereby reduce its reliance on internal drug discovery efforts to keep its pipeline full.

Unlike other major pharmaceutical companies that conducted massive layoffs over the past two years, Lilly was content, until the past few months, to lay off small numbers of employees and offer others retirement packages. Unfortunately, the loss of patent protection on several of its blockbuster drugs coupled with generic encroachment on several brands and impending health care reform, forced Lilly to take more draconian action.

Layoffs have been something of rarity in the life sciences sector over the past eight months or so, but this is usually the time that marks the beginning of the corporate “layoff season.” Don’t be surprised if other large life sciences companies announce similar layoffs in the coming months. Luckily, the economy seems to be improving and there are signs that hiring is beginning to ramp up in the pharmaceutical, biotechnology and devices industries.

Speaking of pink slips, those of you who have been downsized or find yourself out of a life sciences job may be interested in a new organization called Pink Slip mixers. According to a description on the group’s website:

“Our Pink Slip Mixers are about hundreds of professional, mid- to upper-level executives who are (might be) victims of the "economic downturn" of 2008. Our parties are about banding together, networking and bonding with the recently "Pinked". We will share our experiences of why we were let off, what companies are hiring, and the "buzz words" that specific hiring managers want to hear. Aside from the usual imbibing, commiseration and fun that every pink slip party brings, headhunters, direct-hire companies, and recruiting firms will also on-hand to learn a little bit more about what you do. Maybe you'll meet a new contact, or find a new job!” 

Sounds like these mixers might be good networking opportunities and a place to kick back and commiserate with others who are no longer gainfully employed. I am planning to attend a Pink Slip Mixer when one is organized in the NYC metropolitan area. Like many of you, I lost my full time contract copywriting job over a year ago!

Until next time...

Good Luck and Good Job Hunting!!!!

 

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The whole world is atwitter about Twitter (pun intended). One of the reasons why social media tools like Twitter are so effective is that information can reach very large audiences almost instantaneously.

While there are constitutional guarantees of free speech in the US and elsewhere, there are certain things that are safe to tweet and others that are not. This is especially true if you are corporate employee or a jobseeker looking for a new opportunity. While this ought to be intuitively obvious to most, younger and less well-experienced individuals may not know the “unwritten rules” pertaining to office workplaces and job searching.  To that end, there is a wonderful post on the Resume Bear website(@ResumeBear) that lists 20 things that jobseekers and employees should never say on Twitter.  Although some of the examples and recommendations are comical and funny, getting fired or not getting a job because of something you might have said on Twitter isn’t. 

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

 

 

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Despite dire predictions, the biotechnology industry appears to be weathering the recession better than most. According to a CNN Money.com post “Biotechnology leapt ahead as the biggest recipient of U.S. venture capital money in the second quarter, but first-time venture investments in companies overall dropped to a 15-year low.”

Biotechnology funding grew 54% to $888 million in 85 deals, software came in flat at $644 million in 135 deals and Internet companies fell 15% to $524 million in 124 deals. While biotechnology company investments are leading the pack, the current funding levels pale in comparison to those of the late 1990s and early 2000s. Also, it is important to note that many of the biotechnology company investments were in mid to late stage ventures. Fewer investments were made in seed or early stage companies which historically have outpaced funding in late stage ones.

Venture capitalists may be favoring biotechnology investments because there is a clear exit strategy—there are more acquisitions and initial public offerings in life sciences as compared with other industries.

Look for continuing investments in the biotechnology sector—especially in molecular diagnostics and medical devices.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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It’s no secret that major pharmaceutical companies are no longer investing in internal drug discovery initiatives as much as they have in the past. However, I was unaware how drastic the decline in R&D spending was until I read an article entitled “Significant Change Predicted for Bioindustry” by Benjamin J. Conway in the July issue of Genetic Engineering & Biotechnology News. 

Mr. Conway notes that in 1989 more than 50% of the pharmaceutical industry’s budget was spent on preclinical drug discovery and development. During the 1990s, the percentage slowly declined and was approximately 44% by 1999. He asserts that beginning in 2000, “the drop became precipitous” as pharmaceutical companies spent increasing amounts of their R&D budgets on downstream activities including expanded clinical trials. By 2006, big pharma was spending about 25% of its budget on R&D. Strikingly, Mr. Conway contends that “when measured in terms of constant absolute dollars, spending on pre-clinical R&D activities actually declined 0.4% annually over the period, despite annual increases of nearly 7% in total R&D spending.” 

Not surprisingly, the almost decade-long decrease in pharmaceutical R&D spending is best reflected in the lack of new drug approvals over the past five years or so. According to Mr. Conway, throughout the 1990s more than 50% of all new drug approvals originated at big pharma companies. By 2001, these companies were responsible for approximately 60% of new drug approvals. However, since then, pharma’s new drug approvals have plunged to 25% to 30% of annual totals. Some analysts suggest that the figure has been as low as 15%. The decline in new drug approvals almost parallels the decrease in R&D spending at most major pharmaceutical companies. Many industry analysts and thought leaders contend that big pharma companies have gotten too big and unwieldy and can no longer innovate. The unprecedented drops in pharma’s new drug approval rates tend to support that assertion. Mr. Conway points out that the so-called “innovation gap” has been filled by biopharmaceutical companies that “today account for 75% or more of new therapeutics developed each year.”

These changing market dynamics suggests that big pharma must reconfigure the business model that it has clung to for the past 50 years to remain competitive. Not surprisingly, almost all of the major pharmaceutical companies have begun to do just that! For example, over the past three years more than 60,000 R&D scientists have lost their jobs with little likelihood that the vacated jobs will ever be resurrected. Further, big pharmaceutical companies have increasingly begun to outsource many R&D activities to Asia, Eastern Europe and elsewhere. Finally, most big pharma companies have publicly demonstrated—through mergers and acquisitions—that biotechnology products as well as small molecules are in their future.

While big pharma may be retrenching and evolving, don’t expect the pharmaceutical industry on internal drug discovery initiatives —or small molecules for that matter— to disappear any time soon. The industry is going through a transitional period and the companies of the future will look only slightly different than they do today. These companies will still be large and well capitalized, but likely more diversified in their product portfolios (which will surely contain biotechnology drugs). Also, they will continue to excel in new product development, marketing and distribution. However, unlike the past, much less emphasis will be placed on internal R&D programs to discover new molecular entities. This means that pharmaceutical R&D operations will remain lean and companies will increasingly rely on M &A and licensing deals (with smaller specialty pharma and biotechnology companies) to keep their pipelines full.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

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BioJobBlog and BioCrowd along with the Business Development Institute, the Journal of Communication in Healthcare and others are co-sponsoring a meeting entitled “Social Media and Healthcare” that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street). Topics that will be covered include:  

1. Managing regulatory and legal issues when planning and implementing social media strategies
2. Is there a role for social media in President Obama’s healthcare reform plans?
3. Why real-time social media tools like Twitter are gaining momentum and when it makes sense to use them
4. How social media has affected crisis communications in the healthcare industry
   
5. Selling social communications projects and proving ROI to senior management
   
6. Creating and participating in communities to achieve communication, educational and branding objectives
7. Planning and executing a social communications plan with little or no budget
8. Building relationships and partnerships with new healthcare media leaders beyond advertising
9. Best practices for using social communications to connect internally with employees and stakeholders
   
10. Tools, technologies, and best practices for monitoring and measuring social communications

The meeting’s agenda features case study presentations and a series of roundtable discussions on social media topics. I will be leading a roundtable discussion called “How to Build a Social Networking Site for Bioscientists.” Approximately 300 senior marketing, communications and media professionals from Fortune 1000, middle market and emerging growth companies are expected to attend from leading pharmaceuticals, medical technology/device companies, managed care providers, hospitals, healthcare media companies, government and nonprofit organizations.  

BioCrowd members can register for the meeting at a discounted rate of $155. Check it out—it will be money well spent!

Hat tip to Steve Etzler at the BDI and Mario R. Nacinovich Jr., Editor-in-Chief, Journal of Communication in Healthcare for organizing this topical and important meeting.

I hope to see you at the meeting next Thursday!!!!

 

 

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Mark Senak, who writes the outstanding Eye on FDA blog, posted an interesting article today that tracks the number of warning letters issued by DDMAC (the center that oversees life sciences marketing and advertising) over the past 12 years. Not surprisingly, the number of warning letters issued by DDMAC fell precipitously during the Bush Administration, after reaching a high during the waning years of Bill Clinton’s presidency. In fact, the number of warning letters issued by DDMAC during the first two quarters of 2009 exceeds the yearly total of warning letters issued in the past 4 of five years. However, as Mark clearly points out, the 2009 year to date number of warning letters may be artificially inflated because of 14 identical ones issued on the same day (April 2) to 14 different companies regarding internet search engine advertising. Nevertheless, it is becoming increasingly apparent that the agency is beginning to emerge from a long slumber and that US regulatory oversight may be entering a new, more scrutinizing era. 

While increasing regulatory scrutiny may be appropriate after 8 years of no regulation at all, it is important that FDA doesn’t overreact and unnecessarily stifle new drug and product development. To that end, I believe that the agency needs to be reorganized, revamped and revitalized to replace its traditionally “reactive” way of doing business with a more “proactive” one.  For example, there is a burgeoning need for regulatory guidance on the use of social media by companies in the pharmaceutical, biotechnology and medical devices and diagnostics industries. Unfortunately, FDA has been unwilling or unable to enunciate a cogent regulatory strategy or any meaningful guidance on this topic. Consequently, many life sciences companies have refrained from using social media because they simply don’t know how to implement it in the current regulatory environment. I believe that FDA, not the companies it regulates, should take the lead on this issue.

Finally, it is becoming increasingly apparent that many companies will continue to refrain from using social media and other Web 2.0 tools until FDA crafts some useful guidance on these topics. Sadly, Web 3.0 is just around the corner and the agency is still struggling with regulatory guidance for corporate websites. Maybe Congress needs to craft some new FDA modernization legislation—it has been 12 years since the last modernization bill was passed!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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The debate, if you can call it that, over whether or not interactive social media platforms like Facebook and Twitter can be used in the life science industry is moving forward at glacial speed. I decided that it was time to propose some ideas rather than continue to admonish the US Food and Drug Administration (FDA) for a lack of guidance.

There are several reasons which may explain the inertia surrounding the adoption of social media by pharmaceutical, biotechnology and medical devices and diagnostics companies. First, and perhaps foremost, FDA has been consistently reluctant to craft any useful guidance on the use of Web 2.0 technologies for research, clinical or promotional purposes. The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is still trying to figure out how to regulate website content. Is it any wonder that FDA is reluctant to tackle the regulatory implications and issues associated with social media platforms like Facebook and Twitter? Second, a majority of social media advocates— who are leading the charge at many life sciences companies—are marketing and advertising executives who tend to look at social media strictly as a promotional tool. Finally, much of what takes place at life sciences companies is proprietary and confidential—information flow between the company and its employees and the public is fastidiously monitored and tightly regulated. Because of this, the life sciences industry’s “process” is intentionally opaque—which is contrary to the goals of social media which is to promote transparency (or the illusion of it).

There is no doubt that the life sciences industry is the most highly regulated industry on the planet. While this represents a formidable challenge for adoption of social media, it is by no means insurmountable—especially if social media is used for purposes other than branding, marketing and advertising. For example, the most straight forward application of social media at life sciences companies would be in the areas of corporate recruitment and employee retention. Many Fortune 500 companies outside of the life sciences industry have been using Facebook, MySpace and LinkedIn for years for recruiting purposes. While not commonly acknowledged, life sciences companies have quietly begun to use Facebook, LinkedIn and MySpace to recruit prospective employees. Interestingly, the new kid on the block—Twitter—looks to potentially be a more powerful recruiting tool than any of its predecessors. Unfortunately, employee retention is no longer a priority at many companies. However, before the economic meltdown a number of companies, most notably Best Buy, were experimenting with social media to retain talented employees.

Another potential use of social media is for pharmacovigilance and adverse events reporting. Companies with approved products on the market are required by FDA (and other regulatory agencies that approved their products) to set up post marketing surveillance programs for adverse events reporting. By law, companies that receive adverse events reports from consumers, physicians or other entities must report them to the regulatory agencies that approved the product. Regulatory agencies maintain adverse events databases for all approved drugs and devices to monitor drug safety.  If designed and implemented correctly, interactive social media platforms like Facebook and Twitter (which operates in real-time) would make excellent pharmacovigilance and adverse reporting tools. Quite coincidentally, John Mack, who runs the Pharma Marketing Blog, reported a partnership between UCB and PatientsLikeMe.com to create a pharmacovigilance reporting platform for UCB products.

Recruiting patients for participation in clinical trials (to assess efficacy and safety of prospective new drugs) has become extremely challenging over the past few years.Traditional patient recruitment strategies include print, television and radio ads and in some instances, websites. All of these recruitment methods are costly, labor intensive and limited in their effectiveness because they only reach small number of prospective clinical trial participants. I contend that Facebook with over 200 million users, LinkedIn with members in over 140 different countries and Twitter which is growing rapidly would be ideal for clinical trial recruitment and retention purposes. Others have also proposed this idea.

Finally, while the use of social media to promote approved drugs and devices may be difficult because of regulatory constraints, it can be utilized to keep the public informed about prospective new medicines and promote a company’s image or brand. There is no question that the public perception of the pharmaceutical industry has been severely tarnished over the last few years.  The industry’s continued lack of transparency and failure to adequately disclose potential safety risks about some approved products continues perpetuate a negative image. One way to restore public trust and confidence is to use social media to actively engage the public in conversation on wellness, addressing unmet medical needs and prospective new medicines and treatments that are being developed. Also, social media platforms could be employed to showcase community outreach programs and discuss educational initiatives to improve science education and training.

Social media is no longer a new phenomenon or technology. It is a legitimate form of communication which has become an integral part of the Web 2.0 experience. I suspect that the life sciences industry will have to make a decision about social media in the not so distant future—or possibly miss a potentially game-changing business opportunity. And, as Ken Kesey aptly said in Tom Wolfe’s ‘The Electric Kool-Aid Acid Test’—“You’re either on the bus…or off the bus.”

 Until next time...

 Good Luck and Good Job Hunting!!!!!!!!

 

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GlaxoSmithKline (GSK) inked a deal yesterday with the Indian generics manufacturer Dr. Reddy’s Laboratories giving it access to over 100 future generic drugs and a gateway to Asia’s emerging pharmaceutical markets. The therapeutic areas covered under the agreement include diabetes, cardiovascular, pain management, gastroenterology and oncology. Dr Reddy’s Laboratories is one of India’s largest generic drug manufacturers. Like many of its competitors, Dr. Reddy’s Laboratories also have active development programs for new biotechnology drugs and biosimilar products.

UK-based, GSK joins a growing number of pharmaceutical companies including Pfizer, Merck and others that have entered into deals with major generic drug manufacturers—or purchased smaller generics companies—to gain access to generics pipelines and an ability to compete in emerging  non-branded pharmaceutical markets. Impending US healthcare reform and downward pricing pressures (resulting from increased global competition) have forced drug makers to reevaluate the role that generic drugs will likely play in future pharmaceutical revenue streams.

While generic drug makers have outstanding manufacturing capabilities, they generally lack the marketing, sales and distribution channels necessary to penetrate foreign markets and quickly ramp up drug sales. I suspect that the number of deals between pharmaceutical companies and generic manufacturers will continue to increase as many of the patents for multibillion, blockbuster drugs continue to expire in the next few years.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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After months of complaints by university officials and scientific organizations, the US State Department announced on Tuesday that it is taking action to speed up the delay-plagued visa process for foreign graduate students and post-doctoral researchers.

For the past few years, foreign science and engineering graduate students and postdoctoral seeking to obtain or renew visas have routinely experienced long delays sometimes taking as long as several months. The problem became so acute that students and researchers who left the US often found themselves stranded abroad, not knowing when their visas might be approved.  Not surprisingly, the delays have caused enormous problems for American universities, which heavily rely on foreign nationals to fill slots in graduate and post-doctoral science and engineering programs. Over the last year or so, visa difficulties having discouraged many scientific organizations from holding meetings in the United States. Some life sciences researchers said the apparent reluctance of the United States to accept them encouraged them to seek work in other countries.

The State Department has hired additional personal to deal with the visa backlog but will not say how long it will take to correct the problem. A state department official indicated that they hope to handle routine visa requests within a two week time frame.

While never officially acknowledged, the Bush Administration intentionally slowed the visa process for foreign researchers to “guard against proliferation of science and technical information.” In other words, the visa backlog was likely intentionally created to prevent foreign drug companies and national scientific agencies from infringing on American intellectual property and patent rights—an ongoing practice that clearly frightened many of the jingoistic officials running the Bush State Department.

However, what the Bush administration failed to understand was that a majority of foreign students who train in the US want to remain here after completion of their studies. The visa backlog and its protectionist intent forced many foreign nationals to forgo their US training and return to their home countries to seek employment. This was beginning to threaten scientific and technical innovation in US laboratories because for the past decade or longer American students have shied away from science and engineering to pursue careers in business and computer science. Ironically, the Bush Administration’s protectionist leanings may have contributed—more than they care to admit—

 to the massive job cuts that have taken place at American life sciences companies in the past few years because of availability of a US-trained work forces in countries like India and China. This provides American life sciences companies with reasonable assurances that preclinical and clinical research outsourced to these countries will be conducted according to US standards. Further, it also provides foreign companies with unbridled access to a growing cadre of US-trained scientists that will enable them to compete on a head-to-head basis with American life sciences companies.

Fortunately, the Obama Administration, unlike the previous one, delivers on its promises and appears to be willing to work hard to restore science and technology to its rightful place in American society.

Until next time...

Good Luck and Good Job Hunting (it may now be possible for many foreign students!)

 

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The National Institutes of Health (NIH) announced on Wednesday that it was creating a new program aimed at “finding treatments for some of the 6,800 rare diseases that collectively affect about 25 million Americans.” 

According to NIH officials, the NIH would work with researchers and patient advocacy groups to identify new molecular entities (NMEs) that represent potential treatments for rare disorders. Once identified, NMEs will be turned over to private companies for further development. Information about molecules that failed to make the cut for further development will be published in scientific and medical journals. The NIH stressed that the goal of the program is to work with the drug industry not compete with it to develop new treatments.

Because many rare diseases only affect a few hundred or a few thousand people, there are little financial incentives or profit motives for companies to develop treatments for them. To stimulate drug development for rare diseases, the US Congress passed The Orphan Drug Act (1983) that offers companies that develop drugs for diseases affecting fewer than 200,000 people tax incentives, financial support for clinical development and seven years of US market exclusivity, i.e. the company can sell the product without competition for seven years. Since its passage, the Orphan Drug Act has been a boon to many biotechnology companies, most notably Genzyme, a profitable biotechnology company whose business model is built almost exclusively on orphan drug development.

NIH’s entry into the orphan drug development arena ought to help speed discovery and development of potential new treatments for orphan indications. It will undoubtedly help to reduce some of the cost, time and risks typically associated will corporate drug discovery. Industry experts suggest that drug discovery can sometimes cost well over $10.0 million and take between two to four years to complete. However, the program is starting with only $24 million this year and is expected to receive the same level of funding each year until 2013. While this may limit the overall effectiveness of the program, it will likely bring government and the drug industry closer to forge new relationships with the common goal of discovering much needed new treatment for orphan indications.

Until next time...

Good Luck and Good Research!!!!!!!!

 

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Pfizer, the world’s largest drug maker, announced on Thursday that it is unveiling a new program that will let people who have lost their jobs and health insurance to keep taking Pfizer medications — for free, and for up to a year. The company will provide more than 70 of its prescription drugs ranging from Viagra to Lipitor at no costs to unemployed and uninsured Americans who lost their jobs since Jan. 1 and have been taking Pfizer drugs for me than three months. It is not clear how much Pfizer will spend on the program and whether or not costs will be capped.

The announcement comes amid massive job losses caused by the recession and a campaign in Washington to rein in health care costs and extend coverage. The move could earn Pfizer some goodwill in that debate after long being a target of critics of drug industry prices and sales practices. The program also likely will help keep those patients loyal to Pfizer brands. Don't be surprised if other pharmaceutical companies announce similar program over the next few weeks.

Pfizer and the rest of the drug industry wants is trying to have a voice in the debate over how to overhaul the U.S. health care system, partly by joining in a pledge this week to help hold down inflation of health costs. In the mean time, drug companies have been raising prices on their drugs, partly to offset declines in revenue as the global recession reduces the number of prescriptions people can afford to fill.

Pfizer ought to be commended on the program and its concern for the health and well being of unemployed and uninsured Americans. However, it is important to point out that this is little more than a high profile, marketing campaign designed to improve the image of drug makers. More important, it is the first public acknowledgement that drug makers are willing to engage legislators in discussions about how to reform healthcare to reduce costs and cut expenditures. 

What really is at stake here is whether or not the US government will begin regulating drug prices as part of a comprehensive healthcare reform package. As many of you may know, the US government, unlike most other governments in the world, cannot negotiate or set prescription drugs prices. Not surprisingly, the US prescription drug market is the largest and most profitable in the world. It will be interesting to see how the US healthcare reform discussion unfolds—clearly a lot is at stake for the American prescription drug industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Twitter, which is currently de rigueur in social media circles, is emerging as one of the most powerful branding and marketing social media tool that has been developed to date.   While other industries are already exploiting Twitter’s powerful marketing reach (to hawk their wares), drug makers have been reluctant to adopt Twitter and most other forms of social media. Industry analysts and company insiders contend that pharma’s reluctance to adopt social media can be attributed to the US Food and Drug Administration’s (FDA) lack of guidance on its use for promotional purposes. At present, it is anybody’s guess when this guidance may be issued, if ever.

Nevertheless, as always, there are a few daring companies willing to “boldly go where no pharma company has gone before”—in this case—Twitter! These companies include Boehringer Ingelheim (BI), Astra Zeneca, Novartis and Pfizer. According to a post on the Advance Market WoRx blog, BI is leading the way among pharma company Twitterers, with 679 following, 745 followers and 47 tweets. AstraZenecaUS has 136 following, 440 followers and 22 tweets. Pfizer has 351 following, 462 followers and 48 tweets.  Novartis has 0 following, 681 followers and 40 tweets (I guess Novartis has a thing” against following people).

Unlike its fellow pharma Twitters, BI—which began using Twitter in November 2008—actually uses it as an interactive and conversational microblogging platform (as it was intended). The other pharma company Twitters use it almost exclusively “as a one-way PR feed” says Ellen Hoenig Carlson at Advance Market WoRx. According to a post on the Pharmafocus website, "Boehringer has incorporated Twitter into its wider communications strategy and is using the site regularly to engage its stakeholders. In addition to posting press releases, BI uses Twitter to recommend web-based information about therapeutic areas and articles that its followers might find interesting or useful. To keep its finger on the pulse of the Twitterverse, BI uses media scanning programs to help monitor online conversations and responds quickly to join in or start up Twitter conversations.”

Kudos to Boehringer for recognizing Twitter’s potential to communicate with patients, physicians and other interested parties. I hope that more pharmaceutical companies begin to use Twitter and other forms of social media to engage and improve communications with their stakeholders.

Until next time...

Good Luck and Good Twittering (or should it be Tweeting?) 

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Earlier this week, the US Food and Drug Administration (FDA) sent warning letters to 14 different pharmaceutical and biotechnology companies to advise them that their approach to Internet advertising is violating federal pharmaceutical advertising and marketing guidelines and regulations. While the agency’s attempt to regulate Internet-based drug advertising is laudable, the fact that warning letters were sent to 14 different life sciences companies means that there is a poor understanding of the regulations regarding use of Internet—and more recently, social media—to market and advertise drugs, medical devices and diagnostics. This isn’t surprising because FDA has yet to issue any meaningful guidance on the use of the Internet and social media to market life sciences industry products. The reluctance of the agency to issue guidance is very puzzling—the use of web based-advertising and social media by life sciences companies has exploded in the past few years.

In a post today on the EyeOnFDA blog, Mark Sendak pointed out that Twitter is fast becoming the medium of choice for life sciences messaging, branding and product promotion. Despite FDA’s lack of guidance on the use of social media, an increasing number of life sciences companies and organizations are using it to stay in touch with their stakeholders and constituents. For example, the Juvenile Diabetes Research Foundation, the Lancet, the New Scientist, Roche, Novartis, AstraZeneca, Boehringer, Cell Therapeutics and Novartis and others have Twitter accounts. Many of these companies also have fan pages or accounts on Facebook. 

It is becoming increasingly evident that the agency will have to issue guidance on social media sooner rather than later. The wide reach, immediacy and highly interactive nature of social media suggest that the current wait-and-see attitude of FDA is no longer feasible. To jump start the discussion, Social Pharmer, a group of life sciences social media enthusiasts are holding an “unconference” in Boston on April 21, 2009. I hope that FDA sends representatives to this grassroots meeting!!!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (DDMAC), has been mute on the subject and hasn’t issue one iota of guidance on the use of social media in the pharmaceutical, biotechnology or medical devices/diagnostic industries.

Mark Senak, a regulatory affairs lawyer and owner of the blog eyeonfda.com, invited Dr. Jean Ah Kang, Special Assistant at DDMAC in charge of Web 2.0 policy development to talk about FDA’s views and ideas about social media and its use in the life sciences industry. Listening to the 15 min podcast would be, according to Mark, “time well spent” for social media advocates in the pharmaceutical, biotechnology and medical devices/diagnostics sectors.

Hat tip and much “love” to Mark who wrote “BTW, I absolutely expect waves of love for this (the podcast)."

Until next time....

Good Luck and Good Listening!!!!!!!!!! 

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I have been accumulating anecdotal information about companies,organizations and institutions that use social media tools like Facebook, Twitter YouTube etc.  I decided to attempt to conduct an informal survey  to determine whether or not the life sciences sector is adopting and embracing social media to meet its objectives (whatever they may be). 

To that end, I constructed a Google Docs spread sheet to collect information for the survey.  Please take a look at the survey and fill in the requested information. I will publish the results of the survey if enough people response to this request.

I look forward to hearing from as many of you as possible. Don't be shy, everything is anonymous!

Until next time...

 

Good Luck and Good Tweeting!!!!!

 

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Twitter, the microblogging platform, is the current rage in social media. According to @Shwen, who writes the Med 2.0 Blog, it grew by 752% in 2008. Shwen is a social media enthusiast who is trying to convince the life sciences industry that Twitter and other social networks can be leveraged to improve drug development and deliver healthcare.

According to a recent post on Med. 2.0, there are currently three pharmaceutical companies that are actively using Twitter: Novartis (@novartis), Boehringer Ingelheim (@Boehringer) and Astra Zeneca (AstraZenecaUS). Also, it appears that Johnson and Johnson (@JNJcomm) launched an account last week. Tweets from @novartis and @Boehringer occur fairly regularly whereas AstraZenecaUS tweets are rare. Unlike YouTube, where pharmaceutical sponsors who create channels can regulate and control content, it is much more difficult to manage Twitter because tweets are in real time, uncensored (for the most part) and can be globally disseminated within seconds.

Despite these issues, Med 2.0’s Shwen muses “I can only imagine that more pharma companies are going to be jumping on board the Twitter-train sooner rather than later. How they use it to engage, on the other hand, is going to vary greatly from company to company. At the very least, I see companies setting up accounts as “listening posts”, but others may choose to engage, like @boehringer does in an informal manner. Whatever the case, Twitter is fast becoming the new dominant space for listening and/or engaging the life sciences community.”

Like Shwen, I believe that it a matter of time before pharma and biotech realize that they must embrace social media (in all of its various forms) to remain competitive in today’s increasingly interconnected marketplace.

For those of you who may be interested, you can follow BioJobBlog (@Biojobblog) and Biocrowd (@Biocrowd) on Twitter too!

Until next time…

Good Luck and Good Twittering

 

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